BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 1962272 · Received January 18, 2011

    Report

    Report Number
    2124215-2011-00848
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    May 19, 2010
    Report Date
    November 8, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED FUNCTIONAL UNDERSENSING OF A SLOW VENTRICULAR TACHYCARDIA. IT APPEARED THAT SENSOR DRIVEN PACING DELAYED THERAPY DELIVERY. THE DEVICE DID DELIVER THE PROPERLY THERAPY AND THE PATIENT SUCCESSFULLY CONVERTED. TECHNICAL SERVICES (TS) HAD DISCUSSED THE EPISODES AND CONFIRMED THAT DEVICE FUNCTION WAS NORMAL PER PROGRAMMING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATES THAT THE PATIENT LATER HAD MULTIPLE ANTI-TACHYCARDIA PACING ATTEMPTS THAT WERE UNSUCCESSFUL AT CONVERTING THE PATIENT'S ARRHYTHMIA. THE RAMP SCHEME ACCELERATED THE PATIENT'S HEART RATE INTO VENTRICULAR FIBRILLATION (VF) RESULTING IN A SYNCOPAL EPISODE. THE DEVICE DID DELIVER A 41 JOULE SHOCK WHICH SUCCESSFULLY CONVERTED THE PATIENT. THE PHYSICIAN REQUESTED TO REPROGRAM THE DEVICE TO ALL BURST THERAPY. NO FURTHER COMPLICATIONS OR INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening T125| 4473| T180| 0158| 4087