BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASCADE EMG/EP/EEG IOM

    MDR report key: 5966099 · Received September 21, 2016

    Report

    Report Number
    5966099
    Event Type
    Malfunction
    Date Received
    September 21, 2016
    Date of Event
    May 18, 2016
    Report Date
    September 1, 2016
    Manufacturer
    CADWELL INDUSTRIES, INC.
    Product Code
    GWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SPINAL SURGERY, THE NEUROSTIMULATOR REP NOTED CHANGED ON THE MONITOR AND EVALUATED THE ELECTRODE PINS ON THE PATIENT. THE REP NOTED BURNS AT THE ELECTRODE PIN SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619421 CASCADE EMG/EP/EEG IOM STIMULATOR, PHOTIC, EVOKED RESPONSE GWE CADWELL INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other MULTIPLE DEVICE IN USE AT TIME. AQUA MANTIS, STRY