BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3053235 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04889
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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 THIS DEVICE SYSTEM DETECTED AN ARRHYTHMIA, WHICH WAS THEN ACCELERATED, WHERE THE PATIENT RECEIVED NUMEROUS SHOCKS FOR ATRIAL FIBRILLATION (AF). THE LOCAL AREA SALES REPRESENTATIVE CONFIRMED THAT THERAPY WAS LIKELY EXHAUSTED AS A RESULT. A SOFTWARE UPDATE TO ENABLE DISCRIMINATORS WAS PERFORMED, AS WELL AS RAISING THE VENTRICULAR TACHYCARDIA (VT) ZONE. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154582 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 0137| E110| 1600| 1793| 6936| T167| 0041| 7218C| MISMATCH| 5076