BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1042961 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33686
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 20, 2008
    Report Date
    August 3, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    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 PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WHICH IS PART OF THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY POPULATION, EXHIBITED A DECLINE IN MONITORING VOLTAGE AND AN INCREASE IN CHARGE TIMES FROM ONE FOLLOW UP APPOINTMENT TO THE NEXT THAT WAS CONCERNING TO THE HEALTH CARE PROVIDER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. TECHNICAL SERVICES ADVISED COMPLETING A SAVE TO DISK FOR ENGINEERING ANALYSIS TO RULE OUT PREMATURE BATTERY DEPLETION. THIS WILL BE COMPLETED AT THE PATIENT'S NEXT SCHEDULED FOLLOW UP APPOINTMENT. THIS ICD REMAINS IMPLANTED. ADDITIONAL INFORMATION INDICATED THAT THIS DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND RETURNED FOR ANALYSIS.

    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 75 YR THE DEVICE 4087/235926 WAS IMPLANTED 19-APR-2005| THE DEVICE 0041/216364 WAS IMPLANTED 23-DEC-1992| THE DEVICE 0041/216365 WAS IMPLANTED 23-DEC-1992| THE DEVICE 0157/128452 WAS IMPLANTED 28-APR-2005| THE DEVICE 0184/101746 WAS IMPLANTED 19-APR-2005