Device product
Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator Intellis Model 97716 Implanted Neurostimulator.
Z-1535-2021
Product summary
- Event
- Event 87674
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 79,616 units
- Official record key
device-enforcement:Z-1535-2021
Official wording
Reason: There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
Code information: All serial numbers
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.