BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1946122 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20249
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 15, 2010
    Report Date
    October 19, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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.

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED WHEN THE PATIENT WAS UPGRADED TO A BI-VENTRICULAR DEVICE. WHILE IN SERVICE, THE DEVICE HAD BEEN PROGRAMMED TO MONITOR ONLY MODE DUE TO INAPPROPRIATE SHOCKS. THE DEVICE REACHED END OF LIFE STATUS DUE TO CHARGE TIME, AND WAS REPLACED AFTER IT REACHED STORAGE MODE. THERE WERE 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 60 YR 6949| T175