BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950334 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22141
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS IN THE TRIAD CONFIGURATION. WHEN THE CONFIGURATION WAS RV COIL TO CAN, SHOCK IMPEDANCE MEASUREMENTS WERE 72 OHMS. IT WAS NOTED THAT ALL OTHER LEAD MEASUREMENTS WERE STABLE AND NORMAL. TECHNICAL SERVICES (TS) DISCUSSED THAT IT APPEARS TO BE ISOLATED TO JUST THE PROXIMAL COIL SINCE THE RV COIL TO CAN WAS NORMAL BUT THE TRIAD CONFIGURATION WAS GREATER THAN 125 OHMS. TS INDICATED THEY COULD LEAVE THE RV COIL TO CAN CONFIGURATION; HOWEVER, THE SHOCK VECTOR HAS CHANGED; THEREFORE, DEFIBRILLATION THRESHOLD (DFT) TESTS MAY CHANGE. TS RECOMMENDED RETESTING DFT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)