BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 1117385 · Received August 14, 2008

    Report

    Report Number
    2124215-2008-37567
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    June 17, 2008
    Report Date
    May 21, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT WAS ADMITTED FOR A LEAD REVISION. THE DEVICE REMAINS IMPLANTED BUT WAS MOVED SUB-MUSCULAR. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD UNEXPLAINED SYNCOPE WHILE DRIVING. UPON DEVICE INTERROGATION SEVERAL EPISODES OF NOISE WERE NOTED ON A NON-BOSTON SCIENTIFIC DEFIBRILLATION LEAD. IMPEDANCE RANGED FROM 500-1115 OHMS IN A THREE MONTH PERIOD. THRESHOLDS INCREASED FROM .6MS TO 2.6V AT .5MS. RWAVES DECREASED FROM 16MV TO 3MV. THE DEVICE WAS LATER EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| R THE DEVICE (B)(4) WAS USED DURING THE EVENT.| THE DEVICE (B)(4) WAS USED DURING THE EVENT.| THE DEVICE 6949 LFJ235 WAS USED DURING THE EVENT.| THE DEVICE 6481 036698 WAS USED DURING THE EVENT.