BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1766339 · Received July 21, 2010

    Report

    Report Number
    2124215-2010-13012
    Event Type
    Malfunction
    Date Received
    July 21, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 3, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT DEFIBRILLATION THRESHOLD TESTING (DFT). THE DFT TESTING RETURNED IMPEDANCE MEASUREMENTS WITHIN RANGE ONCE THE COMPETITORS LEAD WAS ELECTRONICALLY DEACTIVATED. THE DFT TESTING WAS SUCCESSFUL IN A SINGLE COIL CONFIGURATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE DETECTED HIGH, OUT OF RANGE SHOCK IMPEDANCES ON A COMPETITOR'S SUBCUTANEOUS ARRAY.

    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 63 YR 0181| 6996SQ| 4135| E110| 0185