BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NICOLET EDX

    MDR report key: 4817635 · Received May 27, 2015

    Report

    Report Number
    4817635
    Event Type
    Injury
    Date Received
    May 27, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 27, 2015
    Manufacturer
    NATUS NEUROLOGY, INCORPORATED
    Product Code
    IKN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A SINGLE FIBER STIMULATED EMG OF THE LEFT FRONTALIS MUSCLE. THE STIMULATION OF THE EMG WAS ADMINISTERED USING TWO SUB-DERMAL NEEDLE ELECTRODES. UPON REMOVAL OF THE SUB-DERMAL ELECTRODES TWO BURNS WERE NOTED AT THE ELECTRODE PLACEMENT SITES. THE PATIENT WAS SENT TO THE EMERGENCY CENTER FOR EVALUATION AND IT WAS DETERMINED THAT THE PATIENT HAD THIRD DEGREE BURNS. THE MACHINE WAS SEQUESTERED AND EVALUATED BY THE MANUFACTURER.======================MANUFACTURER RESPONSE FOR ELECTROMYOGRAPHY MACHINE, VIKING EDX (PER SITE REPORTER).======================SPOKE WITH FIELD/REPAIR ENGINEERS. THEY WERE TO CONDUCT AN INVESTIGATION. THE RESULTS OF THIS INVESTIGATION HAVE NOT YET BEEN COMMUNICATED TO ANYONE AT THE HOSPITAL. I TRIED SEVERAL TIMES TO CONTACT AN ENGINEER AT THE MANUFACTURER AND HAVE NOT BEEN ABLE TO GET A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343330 NICOLET EDX ELECTROMYOGRAPH, DIAGNOSTIC IKN NATUS NEUROLOGY, INCORPORATED VIKING *

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other| R