BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1851614 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14085
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 20, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-1192-06 THRU Z-1194-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS UNDERGOING DETAILED LABORATORY ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    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. ALL LOW VOLTAGE POWER SUPPLY MEASUREMENTS WERE CURRENTLY WITHIN AN APPROPRIATE RANGE; HOWEVER, FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO LOW VOLTAGE CAPACITOR DEGRADATION, WHICH RESULTED IN A HIGH CURRENT CONDITION. THIS ISSUE IS DISCUSSED IN THE Q2 2010 PRODUCT PERFORMANCE REPORT.

    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 AND WAS REPLACED WITH ANOTHER BOSTON SCIENTIFIC CRT-D. UPON RECEIPT, INITIAL LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE DID NOT MEET EXPECTED LONGEVITY PREDICTIONS AS DESCRIBED IN DEVICE LABELING.

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H170

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 4470| 0185| N119| 4543| H170