BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3052654 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03839
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 1, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE SYSTEM WAS PRESENTED IN THE EMERGENCY ROOM AFTER THE DEVICE DELIVERED A SHOCK. UPON INTERROGATION, THE ARRHYTHMIA BEGAN IN THE VENTRICULAR TACHYCARDIA (VT) ZONE MONITOR ONLY ZONE, WITH ANTI-TACHYCARDIA PACING (ATP) ACCELERATING THE RHYTHM INTO VENTRICULAR FIBRILLATION (VF). THE ONE DELIVERED SHOCK CONVERTED THE RHYTHM. FOLLOWING THE SHOCK, THE RHYTHM MOVED INTO ATRIAL FIBRILLATION (AF). TECHNICAL SERVICES WAS CONSULTED AND DISCUSSED THAT ONCE THE DEVICE RECEIVED THE NEW SOFTWARE, THE INAPPROPRIATE SHOCK WOULD NO LONGER OCCUR. NO FURTHER OBSERVATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155380 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 6942| E110| 5076