BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1617-2015 · Reported May 27, 2015

    Enforcement

    Recall Number
    Z-1617-2015
    Event ID
    71016
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 27, 2015
    Initiation Date
    April 16, 2015
    Classification Date
    May 15, 2015
    Termination Date
    July 22, 2016
    Address
    7000 Central Ave Ne, N/A, Minneapolis, MN, 55432-3568, United States

    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).

    Code Info

    all Serial numbers

    Distribution

    worldwide

    Quantity

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