BEUDAMED
    FDA Recall Terminated

    Medtronic Concerto, C154DWK, Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy, atrial and ventricular therapies. Medtronic, Inc., Minneapolis, MN 55432 USA.

    Recall: Z-0126-2010 · Initiated September 9, 2009

    Recall

    Recall Number
    Z-0126-2010
    Event Number
    53294
    Firm
    Medtronic Inc. Cardiac Rhythm Disease Managment
    FEI Number
    2182208
    Product Code
    NIK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 9, 2009
    Posted
    November 9, 2009
    Terminated
    May 29, 2012
    Address
    8200 Coral Sea St. N.E., Saint Paul, MN, 55112

    Description

    Medtronic Concerto, C154DWK, Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy, atrial and ventricular therapies. Medtronic, Inc., Minneapolis, MN 55432 USA.

    Reason

    A subset of active implanted Concerto CRT-D and Virtuoso ICD devices worldwide (estimated at 6,300) may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. This issue may present in the affected devices as reaching the Recommended Replacement Time (RRT) earlier than projected. This issue does not compromise device functionalit

    Action

    An "Important Medical Device Information" letter, dated September 2009 was hand delivered by Medtronic Representatives beginning 09/09/09. The letter describes the issue, identifies affected devices and provides recommendations for patients with devices in the affected subset.. A Patient letter was mailed to patients beginning 09/28/09. For additional information: Doctors are advised to contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636; Device tracking managers are advised to contact your Medtronic representative, or the Patient Registration Department at 1-800-328-2518 x41832; and Patients are advised to contact Medtronic Patient Services number at 800-551-5544 ext. 41835.

    Distribution

    Worldwide distribution (except Idaho and Wyoming) including countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Norway, Portugal, Saudi Arabi, Spain, Sweden, Switzerland, Turkey and United Kingdom.

    Quantity

    2,011