BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2173793 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-11915
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    May 21, 2009
    Report Date
    July 15, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE 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 RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WHICH WAS INCLUDED IN THE SHORTENED REPLACEMENT WINDOW ADVISORY (B)(6) 2007 POPULATION PRODUCT ADVISORY WAS INITIALLY COMMUNICATED ON (B)(6) 2007, WAS EXPLANTED DUE TO AN UNKNOWN REASON AND RETURNED FOR ANALYSIS. THERE WERE PREVIOUS CONCERNS REPORTED REGARDING THE POTENTIAL THAT THIS DEVICE WAS EXHIBITING THE ADVISORY BEHAVIOR, HOWEVER IT HAD BEEN RULED OUT. UPON RECEIPT, INITIAL LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE WAS EXHIBITING A HIGH CURRENT CONDITION.

    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 51 YR 4469| 4543| H170| 0184| 4549