BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1864183 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16015
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE AND COMPETITOR RA LEAD REMAINS IN-SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CLINIC NURSE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS DEVICE AND COMPETITOR RIGHT ATRIAL (RA) LEAD EXHIBITED A GREATER THAN 2000 OHMS IN (B)(6) 2010. THE PATIENT WAS PRESENTED TO THE CLINIC AND ALL LEAD DIAGNOSTIC MEASUREMENTS WERE NORMAL (440-460 OHMS). THE PATIENT WAS SCHEDULED FOR ANOTHER FOLLOW-UP AND THE CLINIC NURSE WAS PLANNING TO PERFORM POCKET MANIPULATION AND ISOMETRIC EXERCISE IN AN ATTEMPT TO REPRODUCT THE OUT-OF-RANGE (OOR) MEASUREMENT.

    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 23 YR 1788TC| E110| 0180