BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1951052 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23408
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    October 26, 2010
    Report Date
    November 19, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TH DEVICE WAS SUCCESSFULLY INTERROGATED BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. THE PACING, SENSING, AND SHOCKING FUNCTIONS OF THE DEVICE WERE VERIFIED. A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED END OF LIFE (EOL) AFTER EXPERIENCING ONE CHARGE TIME GREATER THAN 30 SECONDS. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, EOL WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM AN IMPLANT FORM THAT THIS DEVICE, WHICH WAS IMPLANTED FOR 58.5 MONTHS, WAS ELECTIVELY EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. END-OF-LIFE (EOL) WAS TRIGGERED IN (B)(6) 2010 WITH A MONITORING VOLTAGE OF 2.68 VOLTS ASSOCIATED WITH A CHARGE TIME OF 33.5 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR (B)(4)| (B)(4)| (B)(4)