Important Safety Alerts

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