BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 2051660 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03235
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    September 22, 2006
    Report Date
    March 9, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS INTERROGATED AND PRESENTED WITH APPROPRIATE BATTERY STATUS AND NO FAULT CODES. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED WITH THIS EVENT. HOWEVER, THE DEVICE WAS LATER EXPLANTED, REASON NOT DISCLOSED, AND RETURNED FOR ANALYSIS. INITIAL ANALYSIS REVEALED A DEVICE ANOMALY.

    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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EMITTED TONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T135

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR (B)(4)| (B)(4)| (B)(4)