BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2042515 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01964
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES DISCUSSED POSSIBLE REASONS FOR THE HIGH IMPEDANCE MEASUREMENTS AND FURTHER TROUBLESHOOTING TECHNIQUES. THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE. THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR FURTHER INFORMATION. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THE PATIENT WAS SEEN IN CLINIC. A MINIMUM AND MAXIMUM ENERGY SHOCK WERE DELIVERED YIELDING MEASUREMENTS OF 108 OHMS AND 106 OHMS RESPECTIVELY. FOLLOWING TESTING SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS WERE OBSERVED. 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 57 YR Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)| (B)(4)