BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1944530 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19604
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH THE CRT-D AND LEAD REMAIN IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A REVISION WAS PERFORMED AFTER NOTING THAT THE PACING IMPEDANCE MEASUREMENTS WERE ABOVE 2000 OHMS. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS NOT PROPERLY CONNECTED TO THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). ONCE THE LEAD WAS RECONNECTED TO THE DEVICE, ALL MEASUREMENTS WERE WITHIN NORMAL RANGE. 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 F102

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention N118| MISMATCH| 4513| H175| 0158