BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0293-2022 · Initiated November 4, 2021

    Recall

    Recall Number
    Z-0293-2022
    Event Number
    88953
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    EZW
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    November 4, 2021
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

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

    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.

    Action

    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.

    Distribution

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

    Quantity

    10,081 devices