BEUDAMED
    FDA Recall Terminated

    Medtronic GEM DR Implantable Cardioverter Defibrillators, Model 7271

    Recall: Z-0812-04 · Initiated April 2, 2004

    Recall

    Recall Number
    Z-0812-04
    Event Number
    28798
    Firm
    Medtronic Inc. Cardiac Rhythm Managment
    FEI Number
    2182208
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 2, 2004
    Posted
    July 20, 2004
    Terminated
    November 29, 2005
    Address
    7000 Central Ave N.E., Fridley, MN, 55432

    Description

    Medtronic GEM DR Implantable Cardioverter Defibrillators, Model 7271

    Reason

    Some of the devices with suspect capacitors (high voltage capacitors associated with prior notifications in 1999 and in 2000) have had unexpected charge circuit time-outs or charge circuit inactive conditions as the battery voltage nears the level for Elective Replacement of the devices.

    Action

    A letter, dated April 2004, was sent on April 5, 2004 to physicians following patients who had the defibrillators implanted. The letter gave recommendations to physicians for selective replacement of some of the implanted devices and for avoiding the problem. Physicians are being visited by sales representatives to verify notification.

    Distribution

    Nationwide in the United States and worldwide.

    Quantity

    250 units (34 units in the United States)