Medtronic Neuromodulation: 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.

Agency Publication Date: November 24, 2021

Affected Products

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

UDI 00763000186265

Product: Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.

UDI 00763000185152

Product: Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Model 97712), and RestoreSensor SureScan MRI (Model 97714) implantable neurostimulators.

UDI 00763000217921

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88953

Status: Active

Manufacturer: Medtronic Neuromodulation

Manufactured In: United States

Units Affected: 3 products (10,081 devices; 6,406 devices; 10 devices)

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Sources: FDA iRES · Raw API Response

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