BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1870529 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-16835
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 10, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    PHYSICIAN

    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 ANALYSIS SHOWED THIS DEVICE DID NOT MEET LONGEVITY EXPECTATIONS. FINAL ANALYSIS CONCLUDED PREMATURE BATTERY DEPLETION OCCURRED DUE TO A COMPROMISED LOW-VOLTAGE CAPACITOR, WHICH RESULTED IN A HIGH CURRENT CONDITION. DESPITE THIS COMPROMISED CAPACITOR, TESTING CONFIRMED THE DEVICE HAD NORMAL PACING, SENSING, AND DEFIBRILLATION THERAPY FUNCTIONS. THIS DEVICE IS INCLUDED IN THE MAY 12, 2006 ADVISORY ISSUED BY GUIDANT (NOW BOSTON SCIENTIFIC CRM) REGARDING PREMATURE BATTERY DEPLETION POTENTIAL IN A SMALL SUBSET OF ICD AND CRT-D DEVICES DUE TO A FAILURE OF A CAPACITOR FROM A SINGLE LOT. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    INITIAL LABORATORY ANALYSIS OF THIS DEVICE DISCOVERED THAT IT DID NOT MEET LABELED LONGEVITY EXPECTATIONS. THIS EVENT WILL BE UPDATED AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED WITH ANOTHER BOSTON SCIENTIFIC DEVICE, AFTER DECLARING ELECTIVE REPLACEMENT INDICATOR (ERI). SUBSEQUENTLY, THE DEVICE WAS RETURNED FOR ANALYSIS. THERE ARE NO KNOWN FIELD ALLEGATIONS AGAINST THIS DEVICE.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H177

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR MISMATCH| 4457| 1298| 0157| 4480| H220| H177