BEUDAMED
    FDA Recall Terminated

    DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement neurostimulator in the same pocket used for the explanted neurostimulator. Implanting in the same neurostimulator pocket allows for a single-incision procedure.

    Recall: Z-2645-2016 · Initiated June 23, 2016

    Recall

    Recall Number
    Z-2645-2016
    Event Number
    74552
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    MHY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 23, 2016
    Terminated
    September 21, 2017
    Address
    7000 Central Ave, Minneapolis, MN, 55421-1241

    Description

    DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement neurostimulator in the same pocket used for the explanted neurostimulator. Implanting in the same neurostimulator pocket allows for a single-incision procedure.

    Reason

    Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Model 64001 and Model 64002, a safety notification was sent to healthcare professionals to reinforce device specific labeling for the handling of pocket adaptors and system integrity checking during implant procedures.

    Action

    Consignees were sent on 6/23/2016 a "Medical Device Safety Notification," dated June 2016. The letter was addressed to Healthcare Professional. The letter described "Background" information on the problem and product involved in the recall. It also provided "Recommendations" which included "Implanting the pocket adaptor with the neurostimulator" and "Checking system integrity". For questions contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7 am - 6pm CST.

    Distribution

    Worldwide Distribution.

    Quantity

    7,542 in the US and 12,999 outside the US.