BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NIM VITAL FACIAL NERVE MONITOR

    MDR report key: 19485126 · Received June 6, 2024

    Report

    Report Number
    MW5155912
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 5, 2024
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MEDTRONIC NIM VITAL WITH FALSE NEGATIVE. IN THIS SPECIFIC CASE, NIM VITAL DID NOT ALARM WITH PROBE DIRECTLY TOUCHING FACIAL NERVE (NO OVELYING BONE) WITH CURRENT SET AT 1.2MA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171921 MEDTRONIC NIM VITAL FACIAL NERVE MONITOR STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other