BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2163316 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07200
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 31, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD WHEN ANALYSIS HAS BEEN COMPLETED.

    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 RECEIVED INFORMATION THAT THIS DEVICE WAS ELECTIVELY EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THERE WERE NO KNOWN ALLEGATIONS OR COMPLAINTS AGAINST THE DEVICE'S OPERATION, FUNCTIONALITY OR LONGEVITY. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, INITIAL INVESTIGATION REVEALED THAT THE DEVICE DID NOT MEET LONGEVITY ESTIMATES PROVIDED IN DEVICE LABELING. DETAILED ANALYSIS IS PENDING.

    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 N119| H170| 4543| 0148| 1861| 4470