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.
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.
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.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Medtronic has received approval to change the design of the implantable synchromed® ii infusion pump. this change
motor design reduces the likelihood of a temporary or permanent shutdown of the motor, which may lead to interruption of therapy. all synchromed® ii pumps are now being manufactured and distributed with this change.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
The purpose of this letter is to inform you that medtronic has received approval to change the design of the synchromed ii implantable infusion pump, which reduces the likelihood of irreversible motor shutdown, which may otherwise result in interruption of therapy.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
This communication is an update to medtronic’s march 2014 notification regarding the potential for synchromed ii
pump overinfusion. this notification provides updated information related to contributing causes, occurrence
rate and patient management recommendations. consistent with the march 2014 communication, medtronic is
not retrieving synchromed ii pumps from the field or recommending prophylactic replacement of the pumps.
please share the enclosed recommendations and this update with personnel responsible for the management of
patients implanted with a synchromed ii pump.
explanation of the issue:
“overinfusion” is defined as the delivery of more drug volume than the programmed rate, exceeding the pump’s
flow rate accuracy specification. pump reservoir contents aspirated during a refill procedure that are less than
expected may indicate that the pump has overinfused. overinfusion may or may not be associated with clinically
relevant symptoms. when the pump delivers more drug volume than the programmed rate, patients may
experience overdose symptoms, and the pump reservoir will deplete more quickly than expected. patients may
experience underdose or withdrawal symptoms if the drug is depleted prior to the scheduled refill date from an
overinfusing pump. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
This letter is a follow up to the june2013 communication (refer to the attached copy of that letter for a full
description of the issue and potential risks) regarding the synchromed ii priming bolus function and to inform you
that medtronic is updating the model 8870 software application card (to version bbu01) as well as the
synchromed® infusion system labeling to address the issue. the synchromed priming bolus function is intended
to quickly advance drug from the pump reservoir to the catheter tip to allow for therapy initiation while the patient
remains under medical supervision.
the updated 8870 software card mitigates the potential for clinically relevant effects of over-delivery of
unintended drug, such as respiratory depression, loss of consciousness, or death, during the full system priming
bolus procedure. the therapy applications on the software card for deep brain stimulation and spinal cord
stimulation remain unchanged. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
Notas adicionales en la data
Causa
Medtronic has incorporated enhancements to the synchromed® ii pump which decrease the potential for internal electrical
shorting and motor corrosion that can cause loss of therapy. with this communication, there is no new information to share
regarding the safety or performance of the synchromed ii pump. these enhancements are part of medtronic’s ongoing
activities around monitoring and improving upon device performance. all synchromed ii pumps are now being manufactured
with these changes.
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.
the synchromed priming bolus function is intended to quickly advance drug from the pump reservoir to the catheter tip to allow for therapy initiation while the patient remains under medical supervision. although drug is not intended to be delivered to the cerebrospinal fluid (csf) during the priming bolus, mixing of the drug and non-drug (sterile water/csf) fluids occurs at the high infusion rates used during a priming bolus. mixing results in the unintended delivery of drug prior to the end of the programmed bolus, as well as dilution of some of the drug remaining in the catheter at the end of the bolus. patients will receive unintended drug at a high rate of infusion in the csf during the priming bolus, and a period of reduced concentration of drug will occur following the priming bolus.
medtronic has performed preliminary bench testing of pumps and catheters to characterize the extent of drug mixing during a priming bolus. it is clear that the amount of drug delivered during the priming bolus procedure is related to the concentration of the drug; however clinical relevance is not fully understood. as part of the evaluation of the priming bolus, medtronic also reviewed previously reported adverse events of overdose, underdose, and death following an infusion system implant or revision. since drug mixing will occur any time the priming bolus is used with a synchromed pump, it is reasonable to expect that the resulting unintended drug delivery is a contributing factor to adverse events involving overdose and underdose. these adverse events will vary depending on the drug being infused, but could include lack of therapeutic effectiveness, confusion or altered mental state, sleepiness, nausea, respiratory depression, coma or death.
medtronic recommends the following published guidance for managing all patients with intrathecal therapy:
continue use of the priming bolus procedure to ensure that therapy is initiated while the patient is under medical supervision.
monitor all patients following start or restart of intrathecal therapy, as recommended in their field safet notice. the post-procedure monitoring period will depend upon specific drug, dose administered and patient co-morbidities.
consider priming the pump prior to implant in the patient and before connection to the catheter (back table prime) to decrease the risk of overdose, especially in patients receiving higher concentration opioid drug solutions and low total daily dose.
educate caregivers and family members to recognize the signs and symptoms associated with intrathecal drug therapy complications.
patients who are receiving intrathecal baclofen and who receive a catheter-only priming bolus with or without a cap aspiration will take longer to reach full intended drug concentration. dose titration may need to be supplemented with oral baclofen to treat spasticity until the optimal intrathecal dose is obtained.
physicians should advise patients to avoid using concomitant drugs that may cause respiratory or cns depression while intrathecal therapy is being initiated or resumed.
for details, please refer to mhra website
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/
fieldsafetynotices/con286760
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 17 june 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 ii and synchromed el pumps
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning synchromed ii and synchromed el pumps, manufactured by medtronic.
within the synchromed pump, feedthroughs are components that provide an electrically insulated path for current to flow from the electronic circuitry to the motor. an electrical short can occur when ions from the drug solution and humidity permeate through the drug pathway tubing inside the pump and interact with the feedthrough over time. an electrical short circuit in a feedthrough may present as a motor stall or low battery reset/alarm and lead to a loss of or reduction in therapy which may result in the return of underlying symptoms and/or withdrawal symptoms.
patients receiving intrathecal baclofen therapy are at risk for baclofen withdrawal syndrome, which can lead to a life threatening condition if not promptly and effectively treated. surgical revision to replace or remove the pumps may be required for patients with pumps experiencing repeated motor stalls, low battery resets (with or without safe state), or a premature elective replacement indicator.
all synchromed ii and synchromed el pumps can potentially be affected by this issue at any time throughout the life of the device, regardless of drugs used in the pump. the synchromed el has been discontinued and based on medtronic data, at least 90% of the remaining actively implanted synchromed el pumps are near expected end of service.
medtronic has assessed reports of internal feedthrough shorting in the synchromed ii pump since its release in 2004. there have been 380 relevant product events from approximately 181,400 pump implants worldwide. medtronic’s analysis of returned products and reports data shows the cumulative failure probability for internal feedthrough shorting to be approximately 0.28% at 48 months and 0.69% at 84 months post implant.
for synchromed ii, this issue may be exhibited as one or more of the following:
repeated motor stalls with recovery listed in the pump event log, not associated with temporary exposure to a magnetic field (e.G. mri).
multiple “reset - low battery” errors (critical alarm) listed in the pump event log. after a reset, the pump may change to “safe state”. while in safe state, the pump does not deliver at a therapeutic rate.
premature elective replacement indicator (non-critical alarm), which is one that occurs sooner than expected based on implant duration and flow rate.
for synchromed el, this issue may be exhibited as one or both of the following:
motor stall as determined by rotor study
low battery alarm
medtronic does not recommend prophylactic replacement of synchromed ii or synchromed el pumps due to the estimated low occurrence rate, the presence of pump alarms, and the risks associated with replacement surgery. if repeated short duration motor stalls, low battery resets (with or without safe state), or a premature elective replacement indicator occur, replacement surgery should be scheduled for therapy continuation. alternative medical management should be considered if appropriate. furthermore, the manufacturer provided the following ongoing patient management recommendations:
continue to monitor patients closely for the return of baseline symptoms. a return of baseline symptoms may potentially indicate pump failure.
inform patients about the importance of keeping their pump refill appointments and contacting their physician immediately if the pump alarm sounds or if they notice a change or return of symptoms. remind patients to always carry their patient identification card.
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 the identified signs and symptoms appear.
the synchromed ii pump is designed with both critical and non-critical alarms.
increase the critical alarm interval frequency. the critical alarm interval frequency may be changed to sound every 10 minutes.
remind patients, their caregivers, and your appropriate staff members to be alert for pump alarms.
at implant or follow-up visits, perform an alarm test to provide an opportunity for patients and caregivers to hear and differentiate between the critical and non-critical pump alarms.
for patients with a personal therapy manager (ptm), if there is an active alarm, the ptm will show an alarm code when a bolus is attempted.
retrieve and check logs for critical alarm events when interrogating the synchromed ii pump. note that a motor stall with recovery is expected in the event log when the pump is exposed to a strong magnetic field, such as during an mri. medtronic technical services may be contacted for further assistance evaluating critical alarm events on logs.
for the synchromed el pump:
remind patients, their caregivers, and your appropriate staff members to be alert for the low battery pump alarm.
for suspected motor stalls, perform a rotor study to confirm or rule out a motor stall.
for details, please refer to mhra website
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/
fieldsafetynotices/con286830
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 19 june 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 ii implantable drug infusion pump
medical device manufacturer, medtronic, has issued a field safety notice concerning synchromed ii implantable drug infusion pump.
the manufacturer detected an upward shift in reports of occurrence for overinfusion, which is defined as an infusion rate exceeding the programmed infusion rate by more than 14.5% as described in the labeling. when overinfusion occurs, it will result in a volume discrepancy at pump refill, where the volume withdrawn from the pump is less than the volume expected.
the cause for pump malfunction leading to overinfusion remains under investigation and has not been linked to any specific pump lot, drug used, or geographical area.
the manufacturer is not recommending prophylactic replacement of pumps. users are advised to always follow pump refill instructions per the device labeling to allow detection of an overinfusing pump.
the manufacturer advises users to inform them if overinfusion is strongly suspected and return any explanted products to the manufacturer for mechanical and functional analysis.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 18 march 2014.
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 ii implantable drug infusion pump
medical device manufacturer, medtronic, has issued a medical device safety alert concerning its synchromed ii implantable drug infusion pump [model numbers: 8637-20 and 8637-40].
the manufacturer has received approval to implement a design change to the synchromed ii implantable drug infusion pump that reduces the likelihood for non-recoverable motor stall, which can cause loss of therapy. for pumps manufactured prior to this design change, analysis of the post-market data estimates the pump survivability specific to non-recoverable motor stall at six years post-implant to be 97.3% for pumps exposed to on-label drugs and 91.1% for pumps exposed to off-label drugs.
the most common contributing factor to motor stall is shaft wear and this is observed in 59% of synchromed ii pumps returned and analyzed for motor stall. engineering testing estimates that the new design change addresses over 99% of shaft wear and will decrease the occurrence of motor stall.
the manufacturer recommends the synchromed ii infusion system be used according to approved product labeling. reliability for synchromed ii pumps used with off-label drugs will still be lower than pumps used with on-label drugs, regardless of indication.
according to the manufacturer, all synchromed ii pumps are now manufactured with the new design change, although there are limited quantities of these new devices in initial production. to ensure the patients have access to uninterrupted therapy, pumps manufactured prior to this latest change will remain available. once there is sufficient inventory of the pumps with the new design, the manufacturer will no longer distribute pumps manufactured prior to this change.
according to the local supplier, the affected products are distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 15 september 2017.
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.
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
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.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the synchromed pumps. there is no problem with the lioresal intrathecal (baclofen injection) contained in the affected drug refill kits. there have been no patient injuries beyond additional needle sticks associated with this issue.
Acción
Medtronic sent a "Medical Device Removal" letter dated April 2014 hand delivered, e-mail or faxed to affected customers. The letter described the problem and the product affected by the recall. The letter also contained the Action Required, Additional Information (Contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7 am - 6pm Central Time) and requested consignees to complete and fax or e-mail the "Medical Device Removal Reply Form".
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic is conducting a recall of a specific subset of model 8637-20 and 8637-40 synchromed ii implantable drug pumps because the audible alarm could cease to function.
Acción
Customers were sent a Medtronic "Urgent Medical Device Removal" letter dated April 2015. The letter described the problem and the product involved in the recall. The letter described the "Required Actions" which included to quarantine and return the product, complete and return the Customer Confirmation Form, and to share the notification with other customers. For questions, they can contact Medtronic Neuromodulation Technical Services at 1-800-707-0933.
A second letter was sent to Healthcare Professional. The "Urgent Medical Device Correction" letter dated April 2015 described the Nature of the Device Issue, Scope and Likelihood of the Issue, Recommendations, Patient Management Recommendations and Additional Information.
Advise consignees to report any malfunction or adverse event related to a device to Medtronic Neuromodulation Technical Services, at 1-800-707-0933 available weekdays from 7 am - 6pm Central Time, and to FDA'ss MedWatch Program (www.fda.gov/medwatch).
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Implanted Infusion Pump - Product Code LKK
Causa
The sc catheters cannot completely engage with the model 700-04m portal connector. the result of this condition is a possible leakage or disconnect of the sc catheter from the portal during the continuous therapy trial period.
Acción
Medtronic informed all Belgium implanting and managing physicians of the SynchroMed II infusion system. Each customer was mailed a Dear Healthcare Professional letter (Medtronic Urgent: Field Safety Notice) on 4/3/08 providing important safety information and patient management recommendations regarding the device incompatibility. The firm recommends that healthcare professionals do not use SC catheters if a connection with an implantable access port is required. Also, if a continuous infusion trial is required with use of an implantable access port, they should use a model 8711 intrathecal catheter. The firm states that for patients who are currently undergoing a continuous trial with an implantable port, replacing the catheter connector before connecting to the SynchroMedd II using the Medtronic model 8578 revision kit is recommended. Medtronic also recommends discussing the risks of connection failure with patients. Local field reps will personally follow-up with affected customers to confirm and document notification.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Implanted Infusion Pump - Product Code LKK
Causa
The sc catheters cannot completely engage with the model 700-04m portal connector. the result of this condition is a possible leakage or disconnect of the sc catheter from the portal during the continuous therapy trial period.
Acción
Medtronic informed all Belgium implanting and managing physicians of the SynchroMed II infusion system. Each customer was mailed a Dear Healthcare Professional letter (Medtronic Urgent: Field Safety Notice) on 4/3/08 providing important safety information and patient management recommendations regarding the device incompatibility. The firm recommends that healthcare professionals do not use SC catheters if a connection with an implantable access port is required. Also, if a continuous infusion trial is required with use of an implantable access port, they should use a model 8711 intrathecal catheter. The firm states that for patients who are currently undergoing a continuous trial with an implantable port, replacing the catheter connector before connecting to the SynchroMedd II using the Medtronic model 8578 revision kit is recommended. Medtronic also recommends discussing the risks of connection failure with patients. Local field reps will personally follow-up with affected customers to confirm and document notification.