BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1870951 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-16922
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 23, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT, THIS DEFIBRILLATION LEAD WAS SURGICALLY ABANDONED. A NEW LEAD WAS IMPLANTED. THE DEVICE WAS ELECTIVELY REPLACED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED. THE DEVICE WAS RETURNED AND UNDERWENT DETAILED ANALYSIS. VISUAL INSPECTION NOTED DRIED BLOOD IN THE RV HEADER PORT. HOWEVER, THE RV PORT PASSED PIN GAGE TESTING. IN ADDITION, THE RV SETSCREW HAS CROSS-THREADING DAMAGE. THE DEVICE WAS THEN EXPOSED TO AND PASSED SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS. IN CONCLUSION, ANALYSIS WAS INCONCLUSIVE THAT THE CROSS-THREADING DAMAGE CAUSED AND/OR CONTRIBUTED TO THE LOSS OF CAPTURE ALLEGATION AS THE TESTS THAT VERIFY PROPER DEVICE OPERATION RELATED TO THIS ALLEGATION PASSED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DETECTED A LOSS OF CAPTURE ON THIS DEFIBRILLATION LEAD. 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 E102

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 0157| 4135| 0184| E110| E102