BEUDAMED
    FDA Enforcement Class II Ongoing

    Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator

    Recall: Z-1691-2024 · Reported May 8, 2024

    Enforcement

    Recall Number
    Z-1691-2024
    Event ID
    94338
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    May 8, 2024
    Initiation Date
    March 28, 2024
    Classification Date
    April 26, 2024
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568, United States

    Description

    Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator

    Reason

    inability to reprogram one device

    Code Info

    UDI/DI 00643169781719

    Distribution

    International distribution in the country of UK.

    Quantity

    1 unit