BEUDAMED
    FDA Recall 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 · Initiated July 14, 2014

    Recall

    Recall Number
    Z-2259-2014
    Event Number
    68935
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    MHY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 14, 2014
    Posted
    August 18, 2014
    Terminated
    October 6, 2014
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    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.

    Action

    The firm, Medtronic, notified their Consignees on 07/14/2014 via telephone of the recall. Medtronic representative used telephone script to convey the information. The script was directed to Risk Management or Inventory Management. The caller was to inform consignees of the problem and product being recalled. Advised consignees to quarantine the product and provided the Medtronic Device Removal Reply Form to the consignees via e-mail or Fax. The Reply Form included contact information which was to call 1-800-633-8766 in case they needed to contact a Medtronic representative. The completed form is to be faxed back to 1-800-897-3899 or e-mail a PDF to [email protected]. If you have any questions, call 763-526-1294.

    Distribution

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

    Quantity

    6