German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Removal of unused Synchromed® II implantable drug infusion pumps from the market, with an expiration date equal to or prior to December 31, 2018, and replacement by pumps with an improved motor design.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Safety warning related to the lower reliability of Synchromed II pumps when used with non-approved drugs and communication of a design change to reduce the possibility of an engine shutdown.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Withdrawal from the market of certain implantable drug infusion pumps "SynchroMed® II", and recommendations for the follow-up of patients implanted with them, due to a possible interruption in the operation of the audible alarm.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Updating model 8870 of the software application card of the N'Vision medical programmer to correct problems affecting the Synchromed II pumps and devices for deep brain, spinal cord and peripheral nerve stimulation.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Possibility of increasing the risk of stops in the motor of the SynchroMed® implantable infusion pump due to the use of non-approved pharmacological formulations for this pump
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Update of the information regarding the risk of overinfusion with the SynchroMed II implantable pump, manufactured by Medtronic, Inc., USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Risk of overinfusion with the SynchroMed II implantable pump, manufactured by Medtronic, Inc., USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Withdrawal from the market of certain "SynchroMed® II" infusion pumps, not implanted, models 8637-20 and 8637-40, manufactured by Medtronic Inc., USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Information on SynchroMed II Implantable Infusion Pumps, manufactured by Medtronic Inc., USA
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Possibility of certain problems with the Synchromed II® and Synchromed EL implantable pumps, manufactured by Medtronic Inc., USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Possible appearance on the screen of the N'Vision medical programmer, manufactured by Medtronic Inc., of an incorrect replacement date for SynchroMed® II pumps that may result in the pump reaching the end of its life before replacement .
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Update of the Model 8870 software card used in the N'VisionTM 8840 Medical Programmer and the instructions for use of the SynchroMed® II Implantable Infusion Systems, manufactured by Medtronic Inc, USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Notas adicionales en la data
Acción
Removal from the market of certain batches of the product "Model 8551 filling kit used with Synchromed implantable infusion pumps", manufactured by Medtronic Inc, USA.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Notas adicionales en la data
Acción
In agreement with Afssaps and following the discovery of a manufacturing defect on certain devices, the company MEDTRONIC proceeded on June 5, 2008, at the recall of implantable pump lots Synchromed models 8637-20 and 8637-40 not still implanted mentioned in the attached mail and has issued recommendations for the management of patients already implanted by these lots. The implant doctors of these pumps, the directors and local correspondents of materiovigilance of the health establishments concerned in France received the mail of recommendations attached (05/06/2008) (269 ko). The directors and local correspondents of materiovigilance of the health establishments concerned in France have received the attached recall (05/06/2008) (33 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Notas adicionales en la data
Acción
The ANSM has been informed of the implementation of a withdrawal of products by the company MEDTRONIC INC .. The users concerned have received the attached mail (16/03/2016) (253 KB). This safety action is registered with the ANSM under the number 201603222. You will be able to consult its progress on the Directory of the signaling of materialovigilanc. by entering this registration number.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Notas adicionales en la data
Acción
ANSM has been informed of the implementation of a recall made by Medtronic. The users concerned received the attached mail (23/04/2015) (253 KB). This safety action is registered with the ANSM under the number 201504923 .. You will have the possibility of consulting its progress report on the Directory of the reports of materialovigilanc. by entering this registration number.
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
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
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).
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: medtronic synchromed® ii pump
the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning the synchromed® ii pump, manufactured by medtronics inc.
the notice provided important information regarding the “schedule to replace the pump by” date displayed on the model 8840 n’vision® physician programmer and printed reports, for the model 8637 synchromedr ii implantable drug infusion pump.
in some circumstances after a pump’s elective replacement indicator (eri) has occurred, the “schedule to replace the pump by” date may be incorrectly displayed as a series of question marks (??/??/????), or as a date greater than 90 days from the eri date, potentially leading to the pump reaching end of service (eos) prior to replacement.
medtronic has confirmed that an algorithm used in the model 8870 application card software has resulted in nine occurrences of an incorrectly displayed “schedule to replace the pump by” date. it is estimated that there are more than 140,000 synchromed ii pump implants worldwide.
a patient with a pump reaching eos prior to replacement may experience the return of underlying symptoms and/or withdrawal symptoms. intrathecal baclofen patients could experience baclofen withdrawal syndrome, which can be life threatening.
no adverse events have been reported for eight of the confirmed cases, and one intrathecal baclofen therapy (itb) patient experienced decreased therapeutic effect with increased spasticity due to the pump reaching eos prior to replacement.
the manufacturer advised customers to take the following actions:
continue normal follow up schedule, and monitor the estimated number of months until eri.
follow labelled recommendations for pump replacement within 90 days* of eri declaration.
for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm
if you are in possession of the product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic model 8870 software application card used in the 8840 n’vision clinician programmer
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning model 8870 software application card used in the 8840 n’vision clinician programmer, manufactured by medtronic limited.
this field safety notice provides safety information regarding the 8870 software application card used by programmer and is intended to advise users that the card is being updated. the updated version of the software card includes applications that impact (a) synchromed drug infusion systems, (b) deep brain, spinal cord stimulation and peripheral stimulation devices.
(a) synchromed drug infusion therapy
the products affected are synchromed ii pump model 8637 and there are 2 issues: (1) erroneous replace by date; and (2) premature reservoir alarm.
regarding erroneous replace by date,
the updated software corrects the issue previously communicated in medtronic’s field safety notice in march 2012 titled potential display of incorrect "schedule to replace the pump by" date for the synchromed ii pump (medtronic ref. fa535). in some circumstances after a pump’s elective replacement indicator (eri) has occurred, the “schedule to replace the pump by” date may be incorrectly displayed as a series of question marks (??/??/????), or as a date greater than 90 days from the eri date, potentially leading to the pump reaching end of service (eos) prior to replacement.
as of 12 sep 2013, there have been 15 reports of this occurring. if a pump reaches end of service prior to replacement, the patient may experience the return of underlying symptoms and/or withdrawal symptoms.
regarding premature reservoir alarm,
the updated software corrects the potential for premature low and empty reservoir alarms. these premature alarms are due to an incorrect calculation within the 8840 programmer software. the majority of these alarms occur within the clinic immediately following an interrogation.
as of 12 sep 2013, medtronic has received 85 reports of a premature alarm in implanted devices. therapy is not affected and the pumps’ calculated residual volume is correctly displayed on the 8840 programmer even if this issue occurs. however, the only impact to patients is the potential for earlier than necessary refill appointments.
to date, there have been no patient-related, serious adverse events reported due to these issues.
medtronic does not recommend prophylactic explant of devices because these issues are addressed automatically and noninvasively with this software card update. until the software application card is updated to version bbr/01 in programmer:
users may continue to use the present software card.
as identified in the march 2012 notification regarding the erroneous replace by date, users should (1) continue the normal follow up schedule, and monitor the estimated number of months until eri; and (2) follow labelled recommendations for pump replacement within 90 days of eri declaration.
in the case of a low or empty reservoir alarm, review the calculated residual volume displayed on the 8840 programmer to assess if the alarm is premature.
(b) deep brain, spinal cord and peripheral nerve stimulation therapies
the products affected are: (1) activa pc, activa rc and activa sc implantable deep brain stimulator models 37601, 37602, 37603, 37612; (2) restoreultra and restoresensor implantable spinal cord stimulator models 37712, 37714. there are two issues: 1) loss of programmed stimulation; and 2) over-stimulation or stimulation in the wrong area
regarding the first issue,
unexpected loss of stimulation may occur under specific conditions.
the patient programmer or clinician programmer will not indicate a loss of therapy, even though stimulation output will not be delivered to the electrodes.
as of 12 sep 2013, this issue has been reported for a total of 21 devices [10 deep brain stimulation (dbs), 11 spinal cord stimulation (scs)]. in all cases of temporary loss of stimulation, therapy was restored with the physician recharge mode of the implantable neurostimulator recharger.
regarding the second issue,
under a specific set of conditions, typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended.
as of 12 sep 2013, medtronic has received 37 reports associated with this issue. all of these reported events have been for scs devices. there have been no reports associated with dbs.
to date, there have been no patient-related, serious adverse events reported due to these issues.
medtronic does not recommend prophylactic explant of devices because these issues can be addressed non-invasively by the clinician using an 8840 clinician programmer or an implantable neurostimulator recharger using the physician recharge mode.
for loss of programmed stimulation, the model 8870 software application card will be updated to version bbr/01 by medtronic field representative. individual patient needs and/or programmed parameters (i.E. number of programs) may determine whether patients should have their device software updated before their normally scheduled visit.
for over-stimulation or stimulation in the lead electrode other than what was intended, to significantly reduce the likelihood that this issue will occur, patients should avoid over discharge. if inappropriate stimulation does occur, it can be terminated using either a 8840 clinician programmer or in the case of a rechargeable device, by using an implantable neurostimulator recharger and employing the physician recharge mode.
after the software update to version bbr/01, any previous version of the model 8870 software application card should no longer be used and can be returned to medtronic.
furthermore, according to the local supplier, the affected products were distributed in hong kong.
for details, please refer to mhra website:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con316334
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 10 october 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic synchromed implantable infusion pump
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning synchromed implantable infusion pump, manufactured by medtronic limited.
from the manufacturer’s investigation, use of unapproved drugs with synchromed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion.
based on data from medtronic’s implantable systems performance registry, the overall failure rate of the synchromed ii pump at 78 months post implant is 2.4% when used to dispense approved drugs, and 7.0% when used to dispense unapproved drugs. the use of unapproved drugs can lead to intermittent or permanent pump motor stalls which may be reported as a loss of or change in therapy. therapy changes could potentially result in serious injury and/or death.
pumps can experience motor stalls when used with either approved or unapproved drugs, however pump motor stalls have been reported at a significantly lower rate when approved drugs are exclusively used. medtronic continues to investigate motor gear corrosion, which has been identified as a primary contributor to permanent motor stall in both synchromed ii and synchromed el pumps.
to minimize the potential for motor stall, the manufacturer advised user to only use the approved drugs that are identified in the synchromed infusion system labelling. do not use compounded drugs, unapproved concentrations or unapproved formulations. the manufacturer also provided the following recommendations:
continue to monitor patients closely for the possible return of baseline symptoms.
reinforce with patients and caregivers information on the signs and symptoms of withdrawal due to therapy cessation, and the importance of contacting their healthcare provider immediately if these signs and symptoms appear.
the synchromed ii pump is designed with a critical alarm for pump motor stall. for patients implanted with a synchromed ii pump, the critical alarm interval frequency can be changed to sound every 10 minutes.
retrieve logs when interrogating the synchromed ii pump in order to check for motor stall events.
according to the local supplier, the affected products were distributed in hong kong.
for details, please refer to mhra website
http://www.Mhra.Gov.Uk/home/groups/fsn/documents/
fieldsafetynotice/con205372.Pdf
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 20 november 2012.