BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 3043108 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02401
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    December 20, 2012
    Report Date
    February 6, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE DEVICE WAS 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. CHARGE TIMES WHILE IMPLANTED WERE ABOUT 23 SECONDS AND THIS IS WITHIN THE EXTENDED CHART TIME LIMIT FOR MID-LIFE. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECEIVED AN APPROPRIATE SHOCK FOR AN EPISODE IN THE VF ZONE. HOWEVER, THE CHARGE TIMES WERE LONG, AND THE PATIENT EXPERIENCED EITHER PRESYNCOPE OR SYNCOPE WITH THE EVENT. THE EXACT SYMPTOMS WERE UNCLEAR AS THE PATIENT WAS A POOR HISTORIAN. THERE WAS CONCERN THAT THE EXTENDED CHARGE TIME BEHAVIOR OF THE DEVICE MAY HAVE CONTRIBUTED TO THE PATIENT'S SYMPTOMS OR SYNCOPE. SUBSEQUENTLY SURGICAL INTERVENTION WAS PERFORMED AND THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147550 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R 0186| T180