BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2051703 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03456
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    May 31, 2007
    Report Date
    February 23, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 PACING AND SENSING FUNCTION OF THE DEVICE PERFORMED NORMALLY THROUGHOUT TESTING. UPON TESTING THE HIGH VOLTAGE COMPONENT, A POST EXPLANT ISSUE WAS FOUND DURING TESTING THAT REVEALED THE DEVICE DID NOT PASS THE SHOCK IMPEDANCE TEST AND HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE NOTED. THE IMPEDANCE ISSUE FOUND DURING TESTING WAS RELATED TO AN INTERNAL COMPONENT IN THE HIGH VOLTAGE MODULE. THE COMPONENT HAD INSULATION BREAK DOWN BETWEEN COLLECTOR AND EMITTER SIDES OF A TRANSISTOR.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A HIGH SHOCK IMPEDANCE MEASUREMENT DURING THE CHARGE TO SHOCK ON T DURING INDUCTION TESTING, WHICH RESULTED IN THE PROGRAMMER ISSUING A POP UP ERROR MESSAGE. INVESTIGATION REVEALED A LOOSE SETSCREW WHICH WAS TIGHTENED AND RESOLVED THE ISSUE. HOWEVER, IT WAS QUESTIONED HOW THE ERROR MESSAGE COULD BE DISPLAYED PRIOR TO THE SHOCK BEING COMPLETED. TECHNICAL SERVICES ADVISED RETURNING A SAVE ALL TO DISK FOR ANALYSIS. THE LOCAL AREA SALES REPRESENTATIVE REPORTED THAT SINCE THE IMPEDANCE RETURNED TO NORMAL ONCE THE SETSCREW WAS TIGHTENED, NO SAVE TO DISK WAS PERFORMED. THIS ICD REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE REOPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR (B)(4)| (B)(4)| (B)(4)