BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE RX

    MDR report key: 658964 · Received November 14, 2005

    Report

    Report Number
    2124215-2005-10839
    Event Type
    Malfunction
    Date Received
    November 14, 2005
    Date of Event
    July 19, 2005
    Report Date
    July 19, 2005
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT FOLLOWING AN ABLATION PROCEDURE, THIS ATRIAL PACING LEAD EXHIBITED NORMAL PACING IMPEDANCE AND THRESHOLD MEASUREMENTS WHEN THE PATIENT WAS LYING ON THE SIDE. WHEN LYING ON THE BACK, THE IMPEDANCE MEASUREMENTS ARE LESS THAN 200OHMS, THE THRESHOLDS ARE ELEVATED AND THERE IS NO SENSING. AT A SUBSEQUENT LEAD REVISION, PREDISCHARGE IT WAS NOTED THAT THE RIGHT VENTRICULAR DEFIBRILLATION LEAD IMPEDANCE MEASUREMENTS WERE 800-900 OHMS AND THERE WAS NO CAPTURE IN THE VENTRICLE. REEXAMINATION OF THE SYSTEM REVEALED BLOOD IN THE HEADER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE RX IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 0144 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other