BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2040778 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00979
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 19, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING SUBSEQUENT ANALYSIS, 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.

    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 INITIAL ANALYSIS SHOWED THIS DEVICE DID NOT MEET LONGEVITY EXPECTATIONS PER PROGRAMMED VALUES. ADDITIONAL ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. THERE WERE NO KNOWN ALLEGATIONS AGAINST THE DEVICE, AND NO REPORTS OF ADVERSE PATIENT EFFECTS. THIS DEVICE IS INCLUDED IN THE (B)(6) 2007 SHORTENED REPLACEMENT WINDOW ADVISORY POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR T175| 6949