FDA-Device2021-12-01Class II

Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.

Medtronic Neuromodulation
Hazard

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.

Sold states
US Nationwide, including PR. There was government distribution but no military distribution was identified.
Affected count
10,081 devices
Manufactured in
7000 Central Ave Ne, Minneapolis, MN, United States
Products
Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0293-2022

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