BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2170266 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09557
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 6, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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 RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. NO ALLEGATIONS AGAINST THIS DEVICE WERE RECEIVED FROM THE FIELD. THIS EVENT WAS CREATED DUE TO THE INITIAL TESTING PERFORMED BY OUR POST MARKET QUALITY ASSURANCE LABORATORY. INITIAL TESTING NOTED A POSSIBLE PERFORMANCE ISSUE. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 0155| E102| T177| 1793