BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1852663 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14344
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 27, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 ISSUE IS DISCUSSED IN THE Q2 2010 VERSION OF OUR PRODUCT PERFORMANCE REPORT. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION, PER PROCEDURE PAPERWORK. A NEW BOSTON SCIENTIFIC DEVICE WAS SUCCESSFULLY IMPLANTED, WITH NO ADVERSE PATIENT EFFECTS REPORTED. THE EXPLANTED DEVICE WAS RETURNED FOR ANALYSIS.

    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 72 YR H170| 0175| 4470| 4542| 4518| N119