| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00071-1 |
| Product Name/Description |
InterStim & InterStim II
InterStim Model Number: 3023
ARTG Number: 125909
InterStim II Model Number: 3058
ARTG Number: 136721 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
When certain therapy parameters are programmed on the Itrel 3 device platform, the use of the cycling feature and the soft start/soft stop feature may result in a negative impact on battery longevity. This impact on longevity is currently not accounted for by longevity estimation tools (including 8870 software and the System Eligibility Battery Longevity (SEBL) manual) and may result in an earlier than predicted explant. Engineering analysis has shown this to be an issue with the InterStim II (3058) device; however, all Itrel 3 platform devices will be included in the scope of the investigation due to product design and potential root cause discussed in section 3.2. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Medtronic is updating the labelling of the devices to include new information on cycling and its effect on battery longevity. Surgeons are advised that if cycling is being used solely to improve device battery longevity, new information in the product labelling should be considered. This action has been closed-out on 18/07/2016. |
| Contact Information |
1800 668 670 - Medtronic Australasia |