BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1771458 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12739
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    May 5, 2009
    Report Date
    June 10, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1192-06 THRU Z-1194-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THIS ISSUE IS DISCUSSED IN THE Q1 2010 PRODUCT PERFORMANCE REPORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS DEVICE EXHIBITED MUSCLE STIMULATION WHEN PACING IN THE ATRIUM. THE DEVICE WAS LATER EXPLANTED. THERE WERE NO PRODUCT PERFORMANCE ALLEGATIONS AT THE TIME OF EXPLANT.

    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 62 YR T180| S601| 4469| 0158| 6932| 6940| 7278| 4086