—#190097

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.

FDA product code: LGW — Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P840001S450
Affected lot / code info: UDI 00763000217921

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued undated letters on 11/4/2021 via USPS Priority Shipping. The recalling firm has three different letters addressed to the Healthcare Professional depending upon the type of device the wireless recharger is used with (InterStim Micro, product number RS5200; Activa RC, product number RS6200; or RestoreUltra & RestoreSensor, Product number RS7200, which is currently not distributed in the U.S. at this time). The letter gives an issue overview and provides requested actions. Those actions include reinforcing the instructions in the enclosed Patient Quick User Guide with their patients and to attempt to reset the WR if the device appears unresponsive. If the problem is not resolved, then contact information is provided for Medtronic Technical Services. A customer confirmation form dated November 2021 was enclosed to acknowledge the consignee has received the letter.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: US Nationwide, including PR. There was government distribution but no military distribution was identified.

Timeline

Recall initiated: 2021-11-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190097. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.