BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE SG

    MDR report key: 8719912 · Received June 20, 2019

    Report

    Report Number
    2124215-2019-11574
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    November 1, 2018
    Report Date
    June 20, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    UDI-DI
    00802526531248
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THERE WAS AN OUT OF RANGE (OOR) SHOCK LEAD IMPEDANCE MEASUREMENT. THE OVERALL SHOCK IMPEDANCE HAS BEEN ABOUT 100-114 OHMS. THE OOR MEASUREMENT WAS ABOUT 133 OHMS AND HAS BEEN STABLE SINCE THAT MEASUREMENT. TECHNICAL SERVICES DISCUSSED THAT THE HEALTH CARE PROFESSIONAL COULD CONTINUE TO MONITOR THE IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE. THIS REPORT WILL BE UPDATED, SHOULD ADDITIONAL INFORMATION BE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512036 ENDOTAK RELIANCE SG PERMANENT DEFIBRILLATOR ELECTRODES NVY BOSTON SCIENTIFIC CORPORATION 0292 133637 00802526531248

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR