BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1944534 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19749
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    September 22, 2010
    Report Date
    October 13, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Removal / Correction Number
    Z-0863-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A LONGEVITY CALCULATION CONFIRMED THAT THE DEVICE DID NOT MEET LONGEVITY ESTIMATES PROVIDED IN DEVICE LABELING. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO LOW-VOLTAGE CAPACITOR DEGRADATION, WHICH RESULTED IN A HIGH CURRENT CONDITION.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. OVERSENSING ON THE RIGHT ATRIAL CHANNEL WAS REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS. INITIAL LABORATORY ANALYSIS FOUND THE DEVICE DID NOT MEET LONGEVITY EXPECTATIONS PER PROGRAMMED VALUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H215

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR H215| H115| 0154| N118| 4512| 1861| 4053