BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROVISION NERVEANA NERVE LOCATING SYSTEM

    MDR report key: 5716735 · Received June 10, 2016

    Report

    Report Number
    5716735
    Event Type
    Malfunction
    Date Received
    June 10, 2016
    Date of Event
    March 15, 2016
    Report Date
    May 25, 2016
    Manufacturer
    NEUROVISION MEDICAL PRODUCTS, INC.
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE CASE THE NERVANA STIM WAS NOT WORKING PROPERLY. REP WAS CALLED AND ALL POSSIBLE CAUSES WERE ELIMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372564 NEUROVISION NERVEANA NERVE LOCATING SYSTEM STIMULATOR, NERVE ETN NEUROVISION MEDICAL PRODUCTS, INC. 111715A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR