BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1771296 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12278
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 15, 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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE'S PROGRAMMED PARAMETER SETTINGS AND THERAPY HISTORY WERE USED TO ESTIMATE EXPECTED BATTERY USE TO DATE, THEN COMPARED TO ACTUAL USE. OUR INITIAL ANALYSIS SHOWED THIS DEVICE MAY NOT HAVE MET LONGEVITY EXPECTATIONS PER PROGRAMMED VALUES. ADDITIONAL ANALYSIS IS PENDING.

    Additional Manufacturer Narrative · 1

    PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, SUBSEQUENTLY 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 TWO COMPROMISED LOW-VOLTAGE CAPACITORS, WHICH RESULTED IN A HIGH CURRENT CONDITION. LABORATORY TESTING CONFIRMED ALL DEVICE THERAPIES WERE AVAILABLE. THIS ISSUE IS DISCUSSED IN THE QUARTER 2, 2010 PRODUCT PERFORMANCE REPORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED AT END OF LIFE STATUS AND REPLACED WITH NO ALLEGATIONS OR ADVERSE EFFECTS. IT WAS REPORTED THAT THE PATIENT HAD BEEN LOST TO FOLLOW-UP FOR APPROXIMATELY 23 MONTHS. THIS DEVICE IS INCLUDED IN THE (B) (6) 2007 SHORTENED REPLACEMENT WINDOW ADVISORY POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H179

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 4470| 0157| H179| 4512