BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITALITY 2

    MDR report key: 1722284 · Received June 14, 2010

    Report

    Report Number
    2124215-2010-12504
    Event Type
    Death
    Date Received
    June 14, 2010
    Date of Event
    May 20, 2010
    Report Date
    May 21, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. ALTHOUGH THE PHYSICIAN FELT THE ICD FUNCTIONED APPROPRIATELY PER THE PROGRAMMED SETTINGS, DEVICE MEMORY DATA WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (BSC TS) TO BE REVIEWED. 8 EPISODES WERE NOTED. THE FIRST TWO EPISODES WERE INDUCED VENTRICULAR FIBRILLATION (VF) FROM THE DAY OF IMPLANT. EPISODES 3 THROUGH 7 WERE CLASSIFIED AS VF; FAST VENTRICULAR TACHYCARDIA (VT) WHICH THEN ACCELERATED INTO VF. ONE OF THESE EPISODES WAS A NON-SUSTAINED VT, SO THERAPY WAS DIVERTED. THE OTHER FOUR EPISODES WERE TERMINATED SUCCESSFULLY WITH A 31 JOULE SHOCK. THE LAST EPISODE IN DEVICE MEMORY, DATED (B) (6)-2010, DEPICTED VT THAT ACCELERATED INTO VF AND WAS ADEQUATELY DETECTED BY THE DEVICE. HOWEVER, BECAUSE THE LAST BEAT DURING THE DEVICE¿S RHYTHM CLASSIFICATION WAS SLOWER, ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED, PER THE PROGRAMMED SETTINGS. THE ATP WAS UNSUCCESSFUL IN CONVERTING THE ARRHYTHMIA. THE RIGHT VENTRICULAR (RV) SIGNAL CHANGED TO A SLOWER SEQUENCE OF HIGH AMPLITUDE R WAVES, FOLLOWED BY SMALL, CHAOTIC SIGNALS; THIS RESULTED IN RV UNDERSENSING. ALL DAILY MEASUREMENTS WERE WITHIN NORMAL RANGE AND THAT THE DEVICE FUNCTIONED NORMALLY AS DESIGNED AND AS PROGRAMMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING (ATP) DUE TO AN EPISODE DETECTED BY THE DEVICE AS VENTRICULAR TACHYCARDIA (VT). THE ATP WAS NOT EFFECTIVE IN CONVERTING THE ARRHYTHMIA AND THE PATIENT BECAME ASYSTOLIC. THE PATIENT WAS SUCCESSFULLY RESUSCITATED USING EXTERNAL DEFIBRILLATION. THE PATIENT REMAINED IN THE HOSPITAL DUE TO ANOXIC ENCEPHALOPATHY AND SUBSEQUENTLY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O