BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITALITY 2

    MDR report key: 2080008 · Received May 6, 2011

    Report

    Report Number
    2124215-2011-08032
    Event Type
    Death
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 11, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. 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. A REVIEW OF DEVICE ELECTROGRAMS (EGMS) FOUND THE DEVICE HAD UNDERSENSED ONLY ONE BEAT IN AN EPISODE PRIOR TO THE PATIENT'S DEATH. THE UNDERSENSED BEAT LED TO A FIVE SECOND DELAY IN BEGINNING A CHARGE. HOWEVER, THE SHOCK WAS DIVERTED DUE TO NORMALLY SENSED SLOW BEATS. THE REPORTED UNDERSENSING DID NOT LEAD TO A SIGNIFICANT DELAY IN THERAPY. IN THE NEXT EPISODE, THE EGM SHOWED VERY LITTLE HEART FUNCTION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS DEVICE HAD DIED. UPON INTERROGATION OF THE DEVICE, IT WAS NOTED THE PATIENT HAD A VENTRICULAR TACHYCARDIA (VT) EPISODE PRIOR TO DEATH. ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED WHICH SLOWED THE ARRHYTHMIA BELOW THE DETECTION RATE. UNSUCCESSFUL ATP WAS DELIVERED FOR A SUBSEQUENT VT EPISODE, AND THE ARRHYTHMIA DEGENERATED TO VENTRICULAR FIBRILLATION (VF). THE DEVICE WAS UNABLE TO SENSE THE SMALL SIGNALS OF THE VF FOLLOWING THE LARGE SIGNALS. DUE TO THE UNDERSENSING, THE DEVICE WAS CHARGING AND DIVERTING THERAPY. ONE SHOCK WAS DELIVERED, HOWEVER, IT DID NOT CONVERT THE VF AND THE PATIENT DIED.

    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 Death