| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00567-1 |
| Product Name/Description |
Medtronic SynchroMed II Pumps
Model Numbers: 8637-40 and 8637-20
Manufactured before July 2011
ARTG Number: 97770 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic is updating information communicated in July 2011 (RC-2011-RN-00769-3) regarding the failure rate for reduced battery performance in Medtronic Model 8637 SynchroMed II pumps manufactured up to June 2011.
Updated Failure Rate information due to this issue:
- Pumps manufactured Mar 2005 through Dec 2010: 0.13% cumulative probability for pump failure at 72 months after implant. This rate remains within the failure rate upper bound of 0.2% reported in 2011.
- Pumps manufactured from Jan 2011 through Jun 2011: 3.17% cumulative probability for pump failure at 72 months after implant. This failure rate exceeds the upper bound estimate of 0.2% reported in 2011.
A patient with a pump exhibiting reduced battery performance may experience 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. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Medtronic is reinforcing the advice provided in 2011. Medtronic does not recommend prophylactic replacement of SynchroMed II pumps with the prior battery design (manufactured before July 2011) because of the estimated low occurrence rates, the presence of pump alarms, and the risks associated with replacement surgery. If Low Battery Reset (critical alarm) or premature Elective Replacement Indicator (non-critical alarm) or End of Service (critical alarm) occurs, replacement surgery should be scheduled as soon as possible. Further ongoing patient management recommendations are detailed in the hazard alert communication provided to physicians. For further information, please see https://www.tga.gov.au/alert/medtronic-synchromed-ii-implantable-infusion-pump-0 .
This action has been closed out on the 26/09/2018. |
| Contact Information |
02 9857 9297 - Medtronic |