Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Causa
Manufactured by maquet/gettinge – a false blood detection alarm and/or fluid ingress could result in the failure of therapy to patients.
Acción
Note: this MDA is for a different issue to the one described in MDA/2017/027 issued 24 August 2017.Identify all affected devices – see the manufacturer’s Field Safety Notice (FSN) dated 17 July 2017. Products distributed from 24 March 2003 to 16 June 2017 inclusive are affected.
Use an alternative IABP or an alternative therapy for treatment if available.
If no alternative is available, undertake a risk assessment based on a clinical risk-benefit analysis. Affected devices which remain in use should be used in accordance with the manufacturer’s FSN.
Contact Maquet to confirm receipt of the FSN and to schedule both the software and hardware updates to prevent false alarms and installation of gaskets to prevent fluid ingress.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Causa
Manufactured by maxter catheters – patients could accidentally pull off the connector cap and choke on it. (mda/2017/035).
Acción
Return all unused, affected devices to the manufacturer – product codes of affected stock are listed in the Field Safety Notice (FSN).
Ensure relevant healthcare professionals are aware of the FSN.
Follow the FSN actions for managing patients with these NG tubes.
Fill in the acknowledgement form in Annex 1 of the FSN and return it to the manufacturer.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
The MHRA has received a report of the X-ray tube head falling onto the table after the support cable and the backup ‘safety device’ failed simultaneously. The tube head weighs 40 kg and there is a risk of death or serious patient injury if this failure occurs during examination.The X-ray tube head is supported by a metal rope that winds over a pulley system behind the tube support covers. There is a safety device fitted, which should catch the rope if it breaks.Wear on the cable may go undetected as the current service instructions for this device do not require that the whole length of the cable is inspected nor do they require that the ‘safety device’ is inspected.The manufacturer has updated the service instructions and issued a Field Safety Notice, available to download from:X-ray, ancillary equipment and accessories - Mecall Srl - UNISTAT L floor stand.
Causa
(mecall srl) an x-ray tube head has fallen onto the table after the support cable and the backup ‘safety device’ failed at the same time. (mda/2009/014).
Acción
Identify any affected devices.
Immediately remove from service.
Contact the manufacturer.
Ensure that the whole length of the support cable and the ‘safety device’ are inspected following the updated service instructions and are free from defect before returning into service.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Risk of delays in the resumption of drug infusion and in the logging of motor stall events following MRI scanning.Medtronic have found that the SynchroMed EL and SynchroMed II drug pumps do not behave as expected when they are exposed to the magnetic field of an MRI scan. The product labelling states that the magnetic field of an MRI scan will temporarily stop the rotor of the pump and suspend drug infusion for the duration of the MRI exposure for all SynchroMed pumps. The pump should resume normal operation when removed from the MRI magnetic field. However, the following issues have been found:potential delay in resumption of drug infusion following an MRI scan (both models)
potential for pump programming to be altered (both models)
delay in logging of motor stall in the pump memory (SynchroMed II only)
delay in detecting motor stall recovery (SynchroMed II only)There have been nine reported incidents of motor stall and 70 reports of event logging errors worldwide to date.No patient deaths or serious injuries have been reported as a result of these problems.
Causa
(medtronic) risk of delays in the resumption of drug infusion and in logging of motor stall events after mri scans. (mda/2008/087).
Acción
Ensure that departmental procedures are in place for the scanning of patients with Medtronic SynchroMed implantable drug pumps. Where prior consultation with pump management staff has not been possible, consider:alternative imaging techniques if appropriate
more regular observations of the patient until confirmation that the pump has restarted.For all personnel involved in the care of patients with these pumps:Follow manufacturer’s advice regarding these risks (see appendix)Before MRIEnsure that an assessment has been undertaken to determine whether the patient could be safely deprived of their drug for the duration of the scan and until the pump can be interrogated
Ensure there is a Medtronic N’Vision programmer available to interrogate the pump as soon as possible after an MRI scan (and X-ray facilities for roller study on SynchroMed EL)After MRIEnsure that the patient and pump are reviewed promptly following scanning to confirm that therapy has resumed and that pump programming has not been affected. This could include:
close observation for signs of drug underdosing
for patients implanted with SynchroMed II pumps, interrogate the pump with the N’Vision programmer. If motor stall and recovery has not been confirmed after a second interrogation, contact the manufacturer for further advice
for patients implanted with SynchroMed EL pumps, interrogate the pump to identify whether programming has been affected and consider carrying out a roller study (as described in the IFU) to confirm that drug infusion has resumed
Before carrying out any medical intervention (e.g. administering a drug bolus or explanting the pump) consider the possibility of extended motor stall
Do not discharge patients until you have verified that normal drug infusion has resumed
Contact the manufacturer for advice if in doubt about pump status
Report drug pump incidents to the manufacturer and the MHRA
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
An error in the programmer software (revision NNB_01) may lead to false warnings of a low battery status. There is a risk that pre-existing symptoms may return if the device ceases to function when true low or end of service battery warnings are subsequently ignored.There are three ways to measure battery status in the model 3023 InterStim neurostimulator:using the InterStim iCon patient programmer
Automated Measurement feature on N’Vision clinician programmer
Therapy Measurement feature on N’Vision clinician programmer.Medtronic has identified that only the Therapy Measurement feature on the N’Vision programmer is accurate. It is therefore important to interpret all other low battery warnings with caution.In July 2007 Medtronic issued a Field Safety Notice (FSN) to alert users to the potential for false low battery warnings on the clinician and patient programmers and to advise of an accurate way to assess the battery capacity on the clinician programmer (see Appendix). Clinicians were advised that patients experiencing a low battery warning on their programmer (which were subsequently confirmed as false in clinic) should ignore further low battery warnings. The FSN also advised that new software was in development for both clinician and patient programmers to address the issue.In July 2008 Medtronic advised the MHRA that the software upgrade was in the approval process and would not be available for implementation for a further few months.It is possible that some model 3023 InterStim devices are now nearing the end of their life, and so genuine low battery alerts may be ignored (although it should be noted that the end of service (EOS) battery alert on the iCon programmer is valid). This could lead to a device ceasing to function before it can be replaced, and a return of the patient’s pre-existing symptoms.
Causa
(medtronic) error in the programmer software (revision nnb_01) which may lead to false warnings of a low battery status. (mda/2008/065).
Acción
You should:consider the need for in clinic review of battery status for patients who have received multiple low battery alerts on their iCon programmer or if their neurostimulator has been implanted for more than two years
confirm battery status using the N’Vision Therapy Measurement feature, which is a reliable indicator - do not rely on the N’Vision low battery alert in the Automated Measurement feature to assess battery status
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
ICD lead recall due to risk of inappropriate patient shocks, loss of defibrillation therapy and/or loss of pacing output, caused by fracture of the lead conductor.The MHRA has received 23 reports of lead conductor fracture for the above models (6930, 6931, 6948 6949), among approximately 6900 leads distributed in the UK. This includes one ongoing investigation of a fatality which may have been a consequence of lead fracture. Fractures typically occur at two main sites on the lead: one at the ring electrode affecting the anode conductor; the second near the anchoring sleeve tie-down affecting the cathode conductor and occasionally the high voltage conductor.UK incident reports have included:delivering a number of inappropriate shocks
oversensing caused by noise on the lead
an increase in the pace/sense or shock lead impedanceMedtronic has informed the MHRA that it is suspending distribution of all models of the Sprint Fidelis lead and is recalling all un-implanted stock. The company communicated this to all its customers in its ‘Urgent Medical Device Information’ issued on 15 October 2007. This provides important programming advice to help increase the chance of early detection of lead fracture, and reduce the risk of inappropriate therapy. However, it is important to note that all ICD leads, not only Medtronic’s Sprint Fidelis models, are associated with a small risk of conductor fracture once implanted, and the steps identified in Medtronic’s notice would not necessarily identify fractures in all cases.Medtronic had previously issued a ‘Physician Information Letter’ on this lead family in March 2007. Their investigations at that time concluded that variables within the implant procedure may pre-dispose the lead to fracture, with severe bending or kinking of the lead during implantation using the venous access location identified as a risk factor.
Causa
(medtronic) 23 reports of lead conductor fracture for models (6930, 6931, 6948 and 6949), of around 6,900 leads in the uk including an investigation into a fatality. (mda/2007/078).
Acción
Do not implant any Sprint Fidelis ICD leads (models listed above).
Identify and return to Medtronic any of these leads which have not been implanted.
Identify all patients implanted with affected models and arrange a follow-up as soon as practicable (within 8 weeks).
Ensure programming parameters are set to maximise the chance of detecting lead fractures and avoiding inappropriate therapy (in accordance with manufacturer’s advice).
Remind patients of the importance of contacting their follow-up clinic as soon as possible in the event of therapy delivery and/or the onset of any audible patient alert.
Follow up patients at 3-month intervals.Clinicians shouldFollow up all patients as soon as practicable, ideally within eight weeks.
Review the following parameters which can indicate lead fracture:
number of inappropriate shocks
oversensing and noise on the RV Lead
an increase in the lead impedance
an increase in the noise sensing on the noise integrity counter.
Consider provocative testing (eg shoulder/arm movements, and deep respiration by the patient), which may help confirm a suspected lead fracture, although this diagnostic method should not be relied upon alone.
Programme the patient’s ICD where appropriate to the following parameters as outlined in Medtronic’s ‘Urgent Medical Device Information’:
To reduce inappropriate shocks due to oversensing:
Program VF detection for initial number of intervals to detect (NID) to nominal settings (18/24) or longer at clinical discretion and redetect NID to nominal settings of (12/16).
Where clinically appropriate increase the number of intervals to detect in the VT zones.
To increase the chance of detection of lead fracture
Turn ON patient alert pacing, RV and SVC defibrillation impedance.
To optimise effectiveness of the lead impedance alert:
Review V pacing lead performance trend to determine typical chronic impedance value for the patient (typical values for Fidelis leads should be 350-1,000 ohms).
Programme lead impedance alert threshold for RV pacing to 1,000 ohms if the typical chronic impedance for the patient is ≤ 700 ohms, or
Programme lead impedance alert threshold for RV pacing to 1,500 ohms if the typical chronic impedance for the patient is > 700 ohms.
Programme lead impedance alert threshold for RV defibrillation and SVC defibrillation to 100 ohms.Remind patients to contact their follow-up centre immediately after they have received a delivery of therapy or when they are alerted by a ‘BEEP’ from their patient alert.Follow up patients at 3-month intervals, in line with Medtronic’s standard patient follow-up recommendation in their ICD physicians’ manuals.Consider the relative risks of lead extraction against the risk of lead fracture on an individual patient basis. Replacement of fully functioning leads would not be appropriate except in unusual circumstances, in view of the significant risk associated with this procedure. However, it is important to note that the actions listed above can not be guaranteed to detect lead fractures in all cases.Report all instances of lead fracture to the MHRA and Medtronic.Report explants to the National Pacing and ICD Database (see contact on page 3).
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Failure of interconnecting wires within the pacemaker may cause:loss of pacing output from atrial and/or ventricular ports
premature battery depletion
intermittent or total loss of telemetry
undersensing
high lead impedance values
loss of rate response
device reset to manufacturer’s default settingsMedtronic has advised MHRA that some Sigma® pacemakers from the above model ranges may be subject to failures which could result in any of the behaviours listed on page 1. Medtronic issued letters to clinicians about this issue in November 2005 (See Appendices 1 and 2).Medtronic’s analyses of 19 returned Sigma® pacemakers has identified a failure mode where separation of interconnecting wires between certain electronic components, can seriously affect the performance of the device.Analysis has identified that the wire separation is associated with the use of an incorrect cleaning solvent during circuit board manufacturing that contained an antioxidant. The solvent, which was only used for a limited manufacturing period, resulted in surface contamination of electrical connection areas prior to wire bond connection. Extensive testing and analysis by Medtronic has now confirmed that use of this cleaning solvent can lead to a reduction in strength of the wire bond connections and these connections may separate over time. No mean time to failure has been established for this failure mode however there have been no failures less than 17 months post implant.There is no provocative testing that can be performed to identify when any of the affected devices may fail.Failure rates are currently low at approximately 0.05%. To date 19 Sigma® failures have been confirmed where wire bond connections have separated. Medtronic estimate that approximately 28,000 devices remain implanted worldwide. In the UK 1 failure by this mode has been confirmed to date out of an estimated 1700 devices that remain implanted. The UK failure occurred at implant duration of 36 months with the patient presenting with shortness of breath. Subsequent clinical checking confirmed no pacing output or telemetry.Medtronic have received no reports of serious injuries or deaths due to this problem.Affected Sigma® pacemakers may be identified through accessing the Medtronic website http://SigmaSNList.medtronic.com
Causa
(medtronic) failure of interconnecting wires may cause loss of pacing output from atrial and or ventricular ports, premature depletion of battery, intermittent or total loss of telemetry, undersensing, high lead impedance values, loss of rate response, device reset to manufacturer's default settings. (mda/2005/072).
Acción
Identify and return to Medtronic all un-implanted devices that are potentially affected (under ‘Download Documents’ below)
Identify all patients that have affected pacemakers and where last follow-up was longer than six months, arrange for pacemaker follow-up as soon as possible, giving priority to pacemaker dependant patients.
At follow-up confirm that the device is performing as expected. Abnormal device behaviours may include:
intermittent or total loss of pacing output in either or both of the atrial/ventricular ports
intermittent or total loss of telemetry
unanticipated premature battery depletion
unexplained increases in lead impedance(s) in unipolar or bipolar mode
undersensing
loss of rate response function (where applicable and programmed on)
power on reset - return to manufacturer’s default settings
Advise patients to contact their follow-up clinic immediately if they experience return of symptoms (e.g. syncope / light-headedness or shortness of breath).
Consider elective device replacement if any of the above device behaviours are detected, especially for pacemaker dependant patients giving consideration to each patient’s medical history, degree of pacemaker dependency and the relative risks of an invasive procedure.
Consider scheduling subsequent pacemaker follow-up at intervals no longer than six months, for all potentially affected pacemakers, to monitor for signs of device degradation.
Report all incidents of device failure to the MHRA and Medtronic.
Report explants to the National Pacing and ICD Database (see Contacts).
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
MHRA is aware of five incidents in the United Kingdom where the use of diamorphine solution has resulted in malfunction of the SynchroMed® pump. In four of these incidents, pump malfunction led to cessation of drug delivery (motor stalling) resulting in return of patient symptoms. In the remaining incident (still under investigation) pump malfunction led to over-infusion of diamorphine solution and the patient suffered a cardiorespiratory arrest.Failure analysis of the four cases of motor stalling by Medtronic has shown that motor stalling was associated with the long-term administration of diamorphine solution, where the materials of the internal components were damaged. Diamorphine (diacetyl morphine) in aqueous solution will degrade over time, producing an insoluble active compound (6-monoacetyl morphine), which is an acetate and is believed to have caused the damage to the pump.Current Instructions for Use for the SynchroMed® implantable drug pump do not include diamorphine in the list of medications that are compatible with the pump.In October 2002 Medtronic distributed an “Educational Brief: Revised Drug Formulation SynchroMed® Infusion System”, which listed drugs and additives known to be incompatible with the SynchroMed® implantable drug pump. Diamorphine was not included in this listing since its adverse effect had not been recognised at that time. To clarify this situation Medtronic plans to distribute further information shortly.It is estimated that there are 1200 SynchroMed® drug pumps currently implanted in the UK.
Causa
(medtronic) diamorphine solution is incompatible with the implantable drug pump. (mda/2003/035).
Acción
For patients currently receiving diamorphine solution via the SynchroMed® pump, clinicians should consider :changing to an alternative medication compatible with the pump as soon as possible (note that changing the patient’s medication requires careful assessment and observation by experienced personnel);
elective replacement of the pump when patient management dictates.
Clinicians should be aware that other drugs are contraindicated for delivery via SynchroMed® implantable drug pumps. Where doubt exists, check the instructions for use as supplied with the pump, or seek manufacturer’s advice.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Causa
Shiley neonatal and paediatric tracheostomy tubes, manufactured by medtronic (previously covidien): specific product and lot numbers are affected.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Risk of loss of ICD/pacing therapy after elective replacement indicator (ERI) is reached, due to rapid battery depletion occurring approximately two and an half years after implantation.Approximately 69,000 EnTrust devices have been sold worldwide since 2005, with just over 1,000 sold in the UK. To date only 0.15% of single chamber EnTrust ICDs and 0.04% of dual chamber EnTrust ICDs worldwide are reported to have experienced rapid voltage decline. Although the issue does not appear to affect devices implanted for less than 30 months, the failure rate as implant duration increases is as yet unknown.Medtronic issued a Field Safety Notice (38Kb) addressing this issue on 6 March 2012.Fig 1: Medtronic’s analysis of ICD failures
The graph shows examples of a number of ICDs which have experienced rapid voltage drop from 3.0V to 2.61V over a time period ranging from approximately one week to six months.
Note: This graph may not be characteristic of every possible voltage curve drop due to this issue. The sole purpose of this graph is to illustrate rapid voltage decline to 2.61V (ERI), not the duration of time between ERI and EOL.End of life (EOL) is triggered 90 days after ERI or after two excessive charge time events (>16 seconds) or if the battery voltage is 2.55V.In EnTrust devices that experienced rapid voltage decline, time between measurements of approximately 3.0V and 2.61V (ERI) ranged from four to 198 days (mean 71, median 56).In EnTrust devices that experienced rapid voltage decline, time between ERI and EOL ranged from six to 96 days (mean 41, median 26), based upon data available from the 9 ICDs that experienced charge circuit timeout events during automatic capacitor formation prior to device explant.In the event of a battery short circuit the ICD may not be able to provide the required therapy for the three month period generally expected post ERI. Although incidents of charge circuit timeout have occurred, there have been no reports to date of death or serious injury associated with this failure.The rapid voltage drop has been linked to an internal short circuit within the ICD battery. Although the exact root cause is still being investigated by the manufacturer, the issue appears to be specific to EnTrust devices. Failure rate data for other Medtronic ICD models incorporating the same battery model currently indicate that they are not affected. Furthermore, these batteries are not used by other manufacturers.
Causa
(medtronic) once elective replacement indicator (eri) is reached there is a risk of loss of icd/pacing therapy from rapid battery depletion that occurs around 2.5 years after implantation. (mda/2012/014).
Acción
Follow-up all patients with EnTrust ICDs urgently:
within one month if the device has been implanted for more than 28 months
within three months in other cases; in order to:
ensure audible alerts for ‘Low Battery Voltage ERI’ and ‘Excessive Charge Time EOL’ are programmed ON (status can be viewed over CareLink)
advise patients to contact centres immediately if the alert sounds
compare battery voltage with values from previous follow ups for evidence of rapid battery voltage drop (see Fig 1).
Replace ICDs where ERI has been reached in the presence of rapid battery voltage drop, within two weeks.
Continue to review all patients every three months.
Ensure all patients are enrolled on CareLink, in discussion with the manufacturer.
Prophylactic replacement of these devices is not recommended except in exceptional circumstances.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Following a software update the new battery impedance elective replacement indicator (ERI) threshold may trigger an unexpected ERI in some EnRhythm® and EnRhythm MRI™ devices.The manufacturer issued a Field Safety Notice (34Kb) (FSN) in August 2011 with patient management recommendations updated from a previously issued FSN (in February 2010), which informed healthcare professionals about a software update.The software update adds a battery impedance ERI threshold that may trigger an unexpected ERI in some devices. Medtronic’s modelling from collected data estimates that approximately 6–10% of devices may reach ERI within five years of implantation. When ERI is triggered, the device reverts to VVI back-up pacing mode (65 beats per minute) which may not be adequate treatment and may cause symptoms associated with pacemaker syndrome for some patients.These pacemakers are no longer sold in the UK and all devices supplied in the UK reached their use by date by 14 August 2011.
Causa
(medtronic) a software update of the new battery impedance elective replacement indicator (eri) threshold may trigger an unexpected eri. (mda/2011/097).
Acción
Schedule all patients who have received the software update for a follow-up visit to identify devices that triggered ERI shortly after the software update.
Patients who have not yet received the software update should be reviewed, and then again within 90 days after the software update to identify if ERI is triggered.
Continue to follow up until device is ready for replacement:
every three months if patient is pacemaker dependent, and
every six months (or at individual physician’s discretion) if patient is not pacemaker dependent.
Schedule device replacement when ERI is triggered.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
The manufacturer issued a Field Safety Notice (FSN) – Medtronic Reference: FA507 (675Kb) – for these devices on 4 April 2011, but has not had sufficient confirmation from users that they have received and acted on this information.A copy of the FSN is in the appendix of this Alert, and it is also available on the MHRA website.
Causa
(medtronic ltd); manufacturer has not had sufficient confirmation from users that they have received and acted on field safety notice (reference: fa507). (mda/2011/060).
Acción
Carry out the actions described in the manufacturer’s FSN, including sending any confirmation requests.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Risk of inappropriate shocks and loss of therapy.Increased risk that the high voltage conductor will fracture if the pace-sense conductor has previously fractured in the same lead.In March 2009 Medtronic issued a Field Safety Notice (FSN) (42Kb) advising clinicians that one option for dealing with this problem was to implant a new pace-sense lead while maintaining the use of the high voltage conductor.However, Medtronic estimates that the survival for the Sprint Fidelis high voltage conductor is 77.7% at 21 months if a pace-sense conductor fracture has previously occurred. Therefore, Medtronic no longer recommends this course of action and has issued another FSN (April 2011) (586Kb). All other patient management recommendations in the March 2009 FSN remain unchanged.
Causa
(medtronic) use of sprint fidelis icd lead could create risk of inappropriate shocks and loss of therapy with model numbers 6930, 6931, 6948 and 6949. (mda/2011/051).
Acción
Identify patients where:the pace-sense conductor has fractured,
a new pace-sense lead has been inserted and
the high voltage conductor remains in use.For these patients, consider the need to implant a new high voltage conductor at elective device change, taking into account the age and clinical circumstances of the patient.If these patients are at high risk of sudden cardiac death in the event of high voltage conductor failure, then consider elective lead replacement before device change.Where a new conductor fracture occurs, implant a new high voltage lead. Where a lead is functioning normally, continue with existing patient management recommendations and use of Medtronic Lead Integrity Alert (LIA). This should be done taking into account the recent update in long term lead survival data presented in the FSN (April 2011) (586Kb).
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Causa
Needle-free iv access device: double octopus extension set with 2 bionectors, anti-reflux valves and clamps manufactured by vygon product code: 0841233 nhs supply chain code: fsw388 lot numbers: 021112af, 081112af and 091112af.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Certain Kappa® and Sigma® series pacemakers may suffer sudden unexpected failure giving rise to bradycardia symptoms (fainting or light headedness). Serious injury or death may occur in pacemaker dependent patients.Medtronic has informed the MHRA that some Kappa® and Sigma® series pacemakers may fail at a higher than expected rate due to separation of wires within the pacemaker electronic circuitry. They issued a Field Safety Notice to address this problem in May 2009. Medtronic has confirmed that, in the UK, approximately 3,500 affected Sigma® and Kappa® pacemakers were distributed and has estimated that approximately 1,100 potentially affected pacemakers currently remain implanted. The 1,100 implants are estimated to represent approximately 2 % of all Kappa ® and Sigma® pacemakers implanted.The separation of the wires within these pacemakers may lead to premature battery depletion, loss of telemetry, loss of output or loss of rate response. This is a sudden pacemaker failure with no reliable means to predict when it may occur.Through post-market surveillance and manufacturing traceability studies, the manufacturer has identified certain pacemakers which may fail at a higher rate due to use of certain lots of a specific component. The manufacturer has yet to establish a specific root cause and is continuing to investigate.This Medical Device Alert also applies to a subset of the Sigma® devices which were already covered by the previous Medical Device Alert issued in December 2005 relating to the lifting of wire bonds due to the use of a cleaning solvent during the manufacturing process.Furthermore, a previous Kappa® advisory of March 2002 also involved the fracture of the wires connecting the electronic circuit to the power supply. However, Medtronic has confirmed that each of the root causes associated with these previous Sigma® and Kappa® advisories is different to that giving rise to the wire separation subject to this current Medical Device Alert.Medtronic has confirmed that the current number of failures reported worldwide represent 0.49 % and 0.88% of the affected Kappa® and Sigma® pacemaker populations respectively. However, the predicted failure rate due to this problem over the lifetime of these pacemakers is 1.1% for Kappa® and 4.8 % for Sigma. Most affected pacemakers have been implanted for five years or longer.
Causa
(medtronic ltd) certain kappa® and sigma® series pacemakers may suddenly fail, which may cause bradycardia symptoms (fainting or light headedness) or serious injury/death in patients dependent on a pacemaker.(mda/2009/038).
Acción
Consider replacing all affected pacemakers in pacing dependent patients.
Advise patients to seek medical treatment immediately if they experience a return of their bradycardia symptoms.
Follow up all other patients implanted with affected pacemakers at intervals of no more than six months.
Report any incidents involving Kappa® and Sigma® pacemaker failures to the MHRA and Medtronic.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Medtronic issued a Field Safety Notice on 17 January 2019 addressing the potential risk of loss of pacing therapy in a specific subset of dual chamber pacemakers. The problem is limited to these pacemakers when programmed to a dual chamber mode with atrial-sensing.156,957 potentially affected devices were distributed worldwide from March 2017 to January 2019 inclusive, with around 7,400 sold in the UK. Devices distributed before March 2017 are not affected.These pacemakers are at risk of experiencing a circuit error following an atrial sensed event, that may result in a device lock-up condition. During the lock-up condition, the pacemaker will not provide atrial or ventricular pacing, neither will it initiate a session with the programmer or CareLink remote monitor or respond to a magnet.For most patients the chance of device circuit error is low, estimated by Medtronic to be around 2.8% per month. This, however, increases significantly for patients in atrial fibrillation, whose pacemaker is atrial sensing, due to the high number of atrial sensed events.The pacemaker will resume normal pacing therapy as soon as an intrinsic ventricular event is detected. Therefore, patients with no ventricular escape rhythm are at greatest risk, as the cessation of pacing will be prolonged. Attention should also be paid to patients previously suspected to have experienced ventricular over-sensing, especially if this resulted in programming changes to ventricular sensing threshold.As of the date of the FSN, there had been 4 non-UK events of clinically apparent pause in 2 patients ranging from 6 to 61 seconds. However, according to the analysis performed by Medtronic using CareLink data, for most patients the duration of the pacing pause would be clinically insignificant in the event of a circuit error, due to the detection of a ventricular sensed event.A software fix mitigating the risk of circuit error is currently being developed by the manufacturer and is estimated to be released in the second half of 2019.
Manufactured by Medtronic Inc – a subset of dual chamber pacemakers may experience a loss of pacing therapy when programmed to a dual chamber mode with atrial-sensing.
Causa
Manufactured by medtronic inc – a subset of dual chamber pacemakers may experience a loss of pacing therapy when programmed to a dual chamber mode with atrial-sensing (mda/2019/008).
Acción
Read the manufacturer's Field Safety Notice (FSN)
Identify all affected devices supplied to your hospital between March 2017 and January 2019 using the serial number look-up tool on Medtronic’s Product Performance website
Additional support in identifying affected devices is available from Medtronic - see details in 'Manufacturer contact
Do not implant affected devices; quarantine them and contact Medtronic to arrange return.
Identify all patients already implanted with an affected device and verify the programmed pacing mode for their pacemaker.
Arrange an in-clinic assessment for all patients with a pacemaker programmed to a susceptible pacing mode see FSN. Prioritise patients without an underlying escape rhythm to prevent syncope who should be seen as soon as possible and ideally within 1 month. Be aware that if these patients are also in atrial fibrillation, this increases the risk of a circuit error occurring.
Follow the recommendations for pacemaker reprogramming included in the FSN.
Consider pacemaker replacement for patients without an underlying ventricular escape rhythm who are unable to tolerate a non-susceptible pacing mode, taking account of their individual procedure-related risk.Report adverse events involving these devices either directly or through your local incident reporting system to your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to the manufacturer.Action byAll cardiologists and cardiac physiologists who manage patients implanted with pacemakers.Deadlines for actionsActions underway:20 February 2019Actions complete:13 May 2019Medical Device Safety Officers (in England): ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.Remember : if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Medtronic has identified that an unpredictable, but very small, subset of InSync III devices may develop unexpectedly high and variable battery impedances, which can reduce the battery voltage to a point where the current is insufficient to support pacing output. Reported harms to date include bradycardia, dyspnoea, complete heart block, weakness and dizziness. Medtronic has received one report of a patient death where it is possible, but unconfirmed, that this issue was a contributing factor.There is no provocative testing that can predict which specific devices may fail, and there is no programming that can mitigate this issue. The failure results from the development of a resistive film on the cathode current collector. Development of the film is erratic and it is, therefore, not possible to identify a specific current drain above which the film will not develop and hence at which the devices are not at risk.To date Medtronic has received 30 reports of devices affected by this issue, which represents 0.03% of those distributed worldwide, all of which have involved devices with implant duration over 53 months. Medtronic predicts the failure rate will be between 0.16% and 0.6% for the remaining active devices, with an associated mortality risk of 0.007-0.02%. This should be compared to Medtronic’s estimated average mortality risk presented by early device replacement of around 0.005%, although clearly this will vary significantly depending upon the patient circumstances.Unfortunately the InSync III models are not supported by Medtronic’s Carelink network, and so it is not possible to review patients remotely.In the UK nearly 6,000 potentially affected devices have been supplied between June 2001 and October 2010 when this product was discontinued, and therefore most devices can be expected to have exceeded 4 years implant duration. To date there have been two incidents associated with this problem reported within the UK.Medtronic issued an FSN to affected hospitals on 10 November 2015 which includes patient management recommendations to mitigate the risk associated with this issue.
Causa
Manufactured by medtronic – battery voltage may reduce to a point where the device is no longer able to provide patient pacing therapy - mda/2015/038.
Acción
Identify all affected patients.
Schedule an early follow up to discuss this issue with the patient, with priority given to pacing dependent patients.
Compare the risk presented by device failure against that associated with device replacement on an individual patient basis. Patient assessment should include review of the:
degree of pacing-dependency
estimated remaining device longevity/time to ERI
applicability of the average mortality risk associated with device failure and device replacement, given by Medtronic (see background).
Be aware that the low risk of device failure does not justify prophylactic replacement for the majority of non-pacing dependent patients.
Repeat the above assessment at each follow-up appointment (intervals of 6 months or less).
Remind patients to contact their follow-up centre if they experience increased symptoms of bradycardia or heart failure (including breathlessness) as this may be an indication of device failure.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Risk of hypoglycaemia due to incorrect selection and delivery of bolus amount.Medtronic has received reports of users accidentally programming the pump to deliver the maximum bolus amount.
Causa
(medtronic) risk due to incorrect selection and delivery of bolus amount. (mda/2014/019).
Acción
Identify affected pumps.Ensure that all staff and patients receive the relevant copy of Medtronic’s Field Safety Notice (FSN) dated March 2014 and follow the recommendations.In particular:When programming insulin doses through the ‘Main Menu’, be aware that scrolling down allows the dose displayed on the screen to go from 0.0 units to the maximum programmed insulin dose.
Always confirm that the insulin dose flashing on the display screen is correct before starting delivery.
Make sure the ‘Max Bolus’ and ‘Max Basal’ settings are programmed according to individual insulin needs as determined by the healthcare professional.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Risk of drug under- or overdose due to various issues with these drug pumps.Medtronic has recently issued four Field Safety Notices (FSN) related to the SynchroMed II and SynchroMed EL implantable drug pumps and accessories:The first FSN (Manufacturer reference: FA573) confirms a serious risk associated with the priming bolus function. Unintentional mixing of drug and non-drug fluids (including cerebrospinal fluid and sterile water) during the priming bolus can pose a risk of overdose. A subsequent risk of underdose exists following administration of the priming bolus. Detailed advice on the management of patients during pump priming is provided in FA573.
The second FSN (FA574) confirms a risk of an electrical short circuit occurring in the feed-through, which provides an electrically insulated path for current to flow from the electronic circuitry to the motor. This issue typically presents itself as a motor stall or low battery reset / alarm and may result in an underdose. Underdose of drug can lead to return of underlying symptoms and / or withdrawal syndrome, a life‑threatening condition for patients receiving intrathecal baclofen therapy. Detailed advice on setting / interpreting alarms and reading alarm event logs is provided in FA574.
The third FSN (FA578) has been issued to notify clinicians that the product labelling has been updated to include the advice on pocket fills, which was originally given in an earlier FSN (FA496).
The fourth FSN (FA579) confirms the recall of certain connectors manufactured before a recent design improvement. These ‘Sutureless Connector Intrathecal Catheter connectors’ may exhibit a greater potential for misalignment and subsequent occlusion, which can lead to an underdose. Full details of how to identify devices for return are provided in FA579.Note: An earlier FSN (FA535, issued in March 2012) relating to erroneous end of service messages, which can result in a drug underdose, also remains relevant as the manufacturer’s software solution has not yet been implementedAll these FSNs are available on the MHRA website.
Causa
(medtronic) 4 field safety notices concerning these products. (mda/2013/042).
Acción
Be aware that Medtronic has recently issued four Field Safety Notices concerning these products. The MHRA has summarised and prioritised the required actions below.
Ensure you follow this advice on device and patient management and, also, the return of sutureless catheter connectors to Medtronic.SynchroMed II and EL:Prime all new pumps prior to implant in the patient or connection to the catheter to reduce the risk of overdose.
Monitor all patients closely after initiation of therapy for up to 24 hours, dependent on specific drug guidelines (see FSN FA573).
Avoid the use of concomitant drugs during therapy initiation that may cause respiratory or CNS depression.
Consider providing an oral baclofen supplement to patients receiving intrathecal baclofen, until the optimal intrathecal dose is obtained.
Reinforce with patients and caregivers information on the various pump alarms (see FSN FA574) and on the signs and symptoms of withdrawal due to therapy cessation.
Continue to monitor patients for the return of baseline symptoms for the life of the implant as this could indicate pump failure due to an electrical short.
Continue to follow advice on the management of device erroneous end of service messages contained within the earlier FSN (see FSN FA535) until a software upgrade has been installed.Sutureless catheter products (used with the SynchroMed pump):
Return all sutureless connector intrathecal catheter products that have a use by date preceding 25 August 2014 (see FSN FA579).
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Risk of compromised insulin therapy, which may lead to severe hypoglycaemia (low blood glucose) or severe hyperglycaemia (high blood glucose). The root causes are:Loose drive support cap (all models)
Damage to pump if immersed in water (all models)
Programming issue related to the sensor graph timeout (Paradigm VEO MMT-554 and MMT-754 only).Loose drive support cap:
Medtronic has received a report of a serious injury related to a loose drive support cap. This may become detached from the pump case, due to impact damage. An attempt to press back the drive support cap may result in an unintended delivery of insulin.
Water damage:
This may result in a pump alarm or may cause the buttons to stop working.
Sensor graph timeout:
This issue only applies to Paradigm VEO (MMT-554 and MMT-754) pump users who are also using both Medtronic ‘Continuous Glucose Monitoring’ and the ‘Low Glucose Suspend’ feature.Paradigm VEO is equipped with a ’Low Glucose Suspend’ feature, which will automatically suspend insulin delivery when glucose levels are too low, to help reduce the risk of severe hypoglycaemia. Basal insulin delivery may not resume in time if the pump user has the ‘Low Glucose Suspend’ feature enabled and has changed the sensor graph timeout setting to “NONE” from the default setting of two minutes. This could result in hyperglycaemia.
Causa
(medtronic) may lead to severe hypoglycaemia (low blood glucose) or severe hyperglycaemia (high blood glucose). (mda/2013/035).
Acción
Identify affected devices.
Ensure that all staff and patients receive a copy of Medtronic’s Field Safety Notice (FSN) dated 28 March 2013 and are aware of the recommendations. In particular:
Discontinue pump use if drive support cap is loose and contact the manufacturer.
Do not immerse the pump in water.
Regularly examine the pump for damage, especially after a shock or drop.
For Paradigm VEO models, check that the default setting for the sensor graph timeout is not ‘NONE’, if the ‘Low Glucose Suspend’ feature is used.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Use of Novabel® dermal filler may cause adverse reactions.Merz Pharmaceuticals GmbH issued a Field Safety Notice (dated 23 July 2010), advising practitioners to stop using Novabel®.The manufacturer has received reports of adverse reactions to the filler including redness, bruising, pain, swelling and histologically confirmed granuloma. They have also received reports of nodules and indurations in the infra-orbital area.
Causa
(merz pharmaceuticals gmbh) manufacturer has received reports of adverse reactions to the filler. (mda/2010/064).
Acción
Do not use Novabel® dermal filler.
Return all unused product to Merz Pharma UK Ltd.
Monitor patients who have received Novabel® and in particular those who exhibit symptoms linked to the use of Novabel®.
If you administer Novabel®:
cease use of the product
return unused syringes to Merz Pharma UK Ltd.
following application, patients should have been advised to return and seek treatment in case of progressive adverse reactions including redness, bruising, pain, swelling, nodules, indurations and granuloma
follow up patients who exhibit residual adverse symptoms (described above) three months after application
where symptoms persist, consider referring patients to a plastic surgeon for further treatment.
If you are a plastic surgeon:
if a patient presents with symptoms linked to Novabel® use, consider the need to treat with minocycline or injectable steroids.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
In May 2018, Newdeal SAS, a company within Integra LifeSciences Group, issued a Field Safety Notice informing distributors and clinicians of devices possibly affected with defective packaging. This defect may result in insufficient sealing, a potential consequence of which is an increased risk of infection.This Medical Device Alert is being issued to ensure that all hospitals are aware of the issue and that adequate action is taken to mitigate potential risk to patients.
Causa
Manufactured by newdeal sas – risk of infection from compromised packaging.
Acción
1.Identify and quarantine all affected devices.
2. Locate and return affected devices to Smith & Nephew as detailed in the Field Safety Notice.
3 Complete the certificate of acknowledgement attached to the Field Safety Notice and return it to the manufacturer.
4. Report adverse events involving these devices to your local incident reporting system, the manufacturer, and your national incident reporting authority: England, Scotland, Northern Ireland, Wales.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
In July 2014, a redesigned cartridge holder for NovoPen Echo and NovoPen 5 was implemented to improve robustness. However, the redesigned cartridge holder can become weakened if it is exposed to chemicals in cleaning agents, sunscreen and food grease, and the snaps keeping the cartridge holder in place may crack or break off.There are 3 types of fault that can occur:‘Snap cracked’
‘One snap broken off’
‘Both snaps broken off’In April 2016 Novo Nordisk decided to change production back to the original cartridge holder so that in future all products would be produced with the original cartridge holder. This was effective from 1 September 2016.Novo Nordisk issued an FSN in July 2017 to recall affected cartridge holders.
Causa
Manufactured by novo nordisk - recall and replacement of specific batches of cartridge holder (mda/2017/024).
Acción
Identify patients who use NovoPen Echo and NovoPen 5 insulin pens and inform them of the manufacturer’s Field Safety Notice (FSN), which lists affected batch numbers.
Advise patients to contact Novo Nordisk directly on the Customer Care line on 0845 600 5055 or to use the manufacturer’s website to check if their device is affected and request a replacement cartridge holder.
Ensure user is able to maintain insulin regime via a suitable device or alternative method.
Discontinue supply of affected devices.
If patients have any questions or concerns, they should contact their doctor, pharmacist or Novo Nordisk’s Customer Care line on 0845 600 5055.
All healthcare professionals should contact Alloga on 01773 515124 to arrange replacements and return affected stock.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Causa
Satella-x ceiling suspended skull x-ray unit. manufactured by nrt. distributed from 1980 to 2006 inclusive.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
Notas adicionales en la data
Risk of injury from detachment of the swing arm.After approximately seven years of use, the plastic spigot joint of the swing arm can fail through fatigue.Ondal issued a Field Safety Notice (61Kb) in December 2012 to the suppliers that use these swing arms. Users should have been informed of this by their respective equipment supplier.
Causa
(ondal) after approximately 7 years of use, the plastic spigot joint of swing arm can fail through fatigue. (mda/2013/020).
Acción
Identify all Ondal swing arms fitted with a plastic spigot.Contact the supplier of the equipment to arrange for them to replace affected swing arms.Users are advised to move lights and monitors carefully until affected swing arms are replaced.