BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle, connected to an extension and leads, which are implanted in the brain.

    Recall: Z-2259-2014 · Reported August 27, 2014

    Enforcement

    Recall Number
    Z-2259-2014
    Event ID
    68935
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    August 27, 2014
    Initiation Date
    July 14, 2014
    Classification Date
    August 18, 2014
    Termination Date
    October 6, 2014
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568, United States

    Description

    Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle, connected to an extension and leads, which are implanted in the brain.

    Reason

    Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing.

    Code Info

    Serial numbers: NKM724776H, NKM724782H, NKM724785H, NKM724790H, NKM724802H, NKM724843H.

    Distribution

    Distributed in the states of: MA, NC, OH, and TX.

    Quantity

    6