BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2052630 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03643
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THE PATIENT IMPLANTED WITH THIS DEVICE WAS IN THE EMERGENCY ROOM. THE PATIENTS RHYTHM WAS IN VENTRICULAR FIBRILLATION (VF) AND IT WAS REPORTED THAT THE DEVICE WAS NOT TREATING THE ARRHYTHMIA APPROPRIATELY. UPON DEVICE INTERROGATION, A SEVEN HOUR EPISODE WAS OBSERVED. COMMANDED SHOCKS THROUGH THE DEVICE WERE DELIVERED, CONVERTING THE PATIENTS ARRHYTHMIA. A TOTAL OF 14 ATTEMPTS TO CONVERT THE ARRHYTHMIA IN THE VT-1 ZONE WITH A RATE OF 130BPM. THE PATIENT RECEIVED MANY BURSTS OF ANTI-TACHYCARDIA PACING (ATP), FOLLOWED BY A 7 J, 21 J AND THREE 41 J SHOCKS, RESULTING IN THERAPY EXHAUSTION. LATER, THE RATE INCREASED TO THE VF ZONE AND THE PATIENT RECEIVED TWO 41 J SHOCKS. A TOTAL OF EIGHT SHOCKS WERE DELIVERED FOLLOWED BY THERAPY EXHAUSTION. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization 0185| E102| T135