BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4132189 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15397
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AVAILABLE INFORMATION SUGGEST THAT THE CHRONIC RV DEFIBRILLATION LEAD AND REPLACEMENT DEVICE REMAINS IN-SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY IN (B)(6) 2014 FOR A SCHEDULED ELECTIVE DEVICE REPLACEMENT PROCEDURE. THE DAILY SHOCK IMPEDANCE MEASUREMENT WHEN CONNECTED TO THE CHRONIC DEVICE HAD BEEN IN THE 70 OHM RANGE. WHEN THE REPLACEMENT DEVICE WAS CONNECTED (IN TRIAD SHOCK CONFIGURATION), THE MEASURED SHOCK IMPEDANCE WAS GREATER THAN 200 OHMS. WHEN THE REPLACEMENT DEVICE WAS REPROGRAMMED DISTAL RV COIL TO CAN, THE MEASURED SHOCK IMPEDANCE WERE WITHIN NORMAL RANGE (75-80 OHMS). THE CHRONIC RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD'S PROXIMAL COIL WAS DISCONNECTED AND THEN RECONNECTED TO THE REPLACEMENT DEVICE. THE TEST BUTTON WAS HELD DOWN AND THERE WAS A WIDE VARIATION IN SEQUENTIAL MEASUREMENTS FROM 37 OHMS TO GREATER THAN 200 OHMS. THE TERMINAL PIN OF THE PROXIMAL COIL WAS REMOVED AND RECONNECTED INTO THE DISTAL PORT OF THE DEVICE. THE SHOCK IMPEDANCE MEASUREMENT WAS STILL GREATER THAN 200 OHMS. THE PROXIMAL AND DISTAL TERMINAL PINS WERE PROPERLY CONNECTED TO THE DEVICE. THE SHOCK VECTOR WAS REPROGRAMMED DISTAL RV COIL TO CAN AND THE MEASURED RV SHOCK IMPEDANCE WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613079 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 0184| T175| E161