BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2052891 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03388
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 27, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND IS CURRENTLY BEING ANALYZED. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED FOR UNKNOWN REASONS. NO DEVICE ALLEGATIONS WERE REPORTED. THIS EVENT WAS CREATED DUE TO THE INITIAL TESTING PERFORMED BY OUR POST MARKET QUALITY ASSURANCE LABORATORY. INITIAL TESTING NOTED A POSSIBLE PERFORMANCE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H175

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR H175| 4244| 0185| 4517