BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1771592 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-13440
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 8, 2010
    Report Date
    June 8, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE STATUS OF THE DEVICE IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT AN UNKNOWN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS HAVING TELEMETRY PROBLEMS. A UNKNOWN FIELD REPRESENTATIVE (POSSIBLE COMPETITOR'S) INQUIRED WHERE THEY COULD SEE IF RADIOFREQUENCY (RF) IS ON, ON THE PROGRAMMER. TECHNICAL SERVICES (TS) EXPLAINED HOW TO DETERMINE IF RF WAS PROGRAMMED ON; HOWEVER, THE FIELD REPRESENTATIVE DISCONNECTED BEFORE INDICATING THE MODEL AND SERIAL NUMBER AND IF RF WAS PROGRAMMED OFF. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE; HOWEVER, WERE UNSUCCESSFUL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1