| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00037-1 |
| Product Name/Description |
SynchroMed II Implantable Infusion Pump
ARTG Number: 97770 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
The SynchroMed II pump software update will automatically correct the following two issues:
1) Erroneous Replace by Date: The updated software corrects the issue previously communicated in Medtronic’s March 2012 (TGA Ref: RC-2012-RN-00260-3) i.e., 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.
2) 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. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
1) Medtronic does not recommend prophylactic explant of devices because these issues are addressed automatically and non-invasively with the software card update. Until the software application card is updated in the programmer:
- Clinicians may continue to use the present software card.
- Continue the normal follow up schedule, and monitor the estimated number of months until Elective Replacement Indicator (ERI).
- Follow labelled recommendations for pump replacement within 90 days of ERI declaration.
2) 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.
- After the software update, any previous version of the model 8870 software application card should no longer be used and can be returned to Medtronic.
For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-synchromed-II-140204.htm . |
| Contact Information |
02 9857 9000 - Medtronic Australasia |