BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 2153676 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-10416
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 10, 2011
    Report Date
    June 29, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THIS DEVICE SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS INVESTIGATION WILL BE REOPENED AND UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED AFTER SEVERAL HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS WERE REPORTED ON THE RIGHT VENTRICULAR LEAD AS WELL AS RISING THRESHOLDS. THE INCREASED IMPEDANCE MEASUREMENTS WERE BELIEVED TO BE DUE TO A LOOSE SETSCREW OR CONNECTION ISSUE WITH THE LEAD AND THE DEVICE HEADER. THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED AND THE LEAD WAS IMPLANTED IN THE REPLACEMENT DEVICE WITHOUT FURTHER ISSUES. TO DATE, THERE HAVE BEEN NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    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 56 YR Required Intervention E102| 0184