BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2780935 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13174
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    January 10, 2012
    Report Date
    September 28, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1620-09 TO Z-1621-09
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT 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 A COMPROMISED LOW-VOLTAGE CAPACITOR, WHICH RESULTED IN A HIGH CURRENT CONDITION. IN SPITE OF THIS COMPROMISED CAPACITOR, TESTING CONFIRMED THAT THE DEVICE HAD NORMAL PACING, SENSING, AND DEFIBRILLATION THERAPY FUNCTIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LONGEVITY ESTIMATE WAS REQUESTED FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE LONGEVITY ESTIMATE FOR THE DEVICE. THE SHORTENED REPLACEMENT WINDOW (4/05/2007) ADVISORY WAS ALSO QUESTIONED. TS DISCUSSED THAT AT 27 MONTHS OF IMPLANT, THE BATTERY VOLTAGE WAS 3.02V, THUS THE DEVICE DID NOT APPEAR TO BE EXHIBITING THE ADVISORY BEHAVIOR. THE CHARGE TIME (CT) WAS ALSO QUESTIONED, AND TS DISCUSSED THE EXTENDED CT FOR THIS DEVICE. THE DEVICE WAS LATER EXPLANTED FOR NORMAL BATTERY DEPLETION (NBD) AND RETURNED FOR ANALYSIS. INITIAL ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY DETERMINED THIS PRODUCT DID NOT MEET LONGEVITY EXPECTATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 0158| T175