BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® EMG ELECTRODE

    MDR report key: 7041957 · Received November 17, 2017

    Report

    Report Number
    1045254-2017-00415
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    October 23, 2017
    Report Date
    November 17, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GXZ
    PMA / PMN Number
    K850107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT PERFORMED; THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THE PURPLE ELECTRODE WAS NOT WORKING. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820193 NIM® EMG ELECTRODE ELECTRODE, NEEDLE GXZ MEDTRONIC XOMED INC. 8227415

    Patients

    Seq Age Sex Outcome Treatment
    1