Device product
Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.
Z-0293-2022
Product summary
- Event
- Event 88953
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10,081 devices
- Official record key
device-enforcement:Z-0293-2022
Official wording
Reason: The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.
Code information: UDI 00763000186265
Distribution pattern: US Nationwide, including PR. There was government distribution but no military distribution was identified.
Derived failure modes
-
Unknown
The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.