BEUDAMED
    FDA Recall Open, Classified

    Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator Intellis Model 97716 Implanted Neurostimulator.

    Recall: Z-1535-2021 · Initiated March 25, 2021

    Recall

    Recall Number
    Z-1535-2021
    Event Number
    87674
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LGW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 25, 2021
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator Intellis Model 97716 Implanted Neurostimulator.

    Reason

    There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.

    Action

    Beginning 25-Mar-2021, Medtronic began notifying physicians in the US and consignees OUS via mail, email, fax, and/or personal visit by Medtronic personnel. In the US, each implanting physician was sent the medical device correction letter, the patient quick guide, and the customer confirmation form. Outside the US, the medical device correction letter, the patient quick guide, and the customer confirmation form were sent to the healthcare facilities. Additionally, on an ongoing basis, the patient quick guide will be provided with each replacement recharger.

    Distribution

    Worldwide distribution.

    Quantity

    79,616 units