BEUDAMED
    FDA Recall Terminated

    Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile

    Recall: Z-1617-2015 · Initiated April 16, 2015

    Recall

    Recall Number
    Z-1617-2015
    Event Number
    71016
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    MHY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 16, 2015
    Posted
    May 15, 2015
    Terminated
    July 22, 2016
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile

    Reason

    Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 37085 and 37086 which can be used with the following implantable Neurostimulators: Activa PC (Model 37601), Activa RC (Model 37612), and the Activa SC (Model 37603).

    Action

    Medtronic began notifying consignees with an Urgent Medical Device Safety Notification letter beginning April 16, 2015. Consignees will be notified by mail and/or in person, by visit of a Medtronic field representative. The letter described the issue and provided recommendations of following the instructions defined within the Neurostimulator implant manual. A Physician Reply Form was asked to be returned via fax at 800-897-3899 or email to [email protected]. Consignees with questions can contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.

    Distribution

    worldwide

    Quantity

    86,851 (US 37,933 / OUS 48,918)