BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3213147 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09872
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 27, 2009
    Report Date
    June 7, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A LONGEVITY CALCULATION CONFIRMED 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 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 OVER THREE YEARS AGO, IT WAS NOTED THIS DEVICE DISPLAYED A RAPID DROP IN BATTERY VOLTAGE, HOWEVER DURING FIELD ANALYSIS WAS DETERMINED TO BE NORMAL BEHAVIOR DURING MIDDLE OF LIFE AND WAS WITHIN SPECIFICATION. THREE YEARS LATER, THIS DEVICE WAS EXPLANTED AFTER DECLARATION OF ELECTIVE REPLACEMENT INDICATOR (ELECTIVE REPLACEMENT INDICATOR (ERI) AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312260 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R 0185| T175