BEUDAMED
    FDA Recall Terminated

    Medtronic Soletra 7426, Quadripolar Multi-Programmable Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc., Minneapolis, MN 55432-5604 USA (The Medtronic Activa System in an implantable, multiprogrammable quadripolar system that delivers electrical stimulation to selected areas of the brain)

    Recall: Z-0694-2008 · Initiated October 1, 2007

    Recall

    Recall Number
    Z-0694-2008
    Event Number
    45847
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    MHY
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    October 1, 2007
    Posted
    February 5, 2008
    Terminated
    May 3, 2012
    Address
    800 53rd Ave NE PO Box 1250, Minneapolis, MN, 55440-1250

    Description

    Medtronic Soletra 7426, Quadripolar Multi-Programmable Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc., Minneapolis, MN 55432-5604 USA (The Medtronic Activa System in an implantable, multiprogrammable quadripolar system that delivers electrical stimulation to selected areas of the brain)

    Reason

    Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy.

    Action

    A letter "Medtronic Urgent: Device Recall" dated October 2007 was sent to Healthcare Professionals. The letter described the device defect, product involved, root cause, probability of occurrence, recommendations and also provided information for assistance. At the time of the recall all of the product remaining in date for use (not expired) had been implanted, therefore Medtronic provided Important Patient Management Information for the implanting physicians to use in patient care and decisions regarding patient explants.

    Distribution

    Worldwide: USA including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, WA, WI, WY, UT, VA, VT, and WV and countries of Australia , Austria , Belgium , Canada , Cyprus , Czech Republic , Denmark , Finland , France , Germany , Greece , Hong Kong , Hungary , Iceland , India , Iran , Israel , Italy , Japan , Latin America, Lebanon , The Netherlands , Norway , Poland , Portugal , Russian Federation , Saudi Arabia , South Africa , Spain , Sweden , Switzerland , Turkey , and The United Kingdom

    Quantity

    1,652