BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSIGN 100 NERVE MONITOR

    MDR report key: 32874 · Received April 26, 1996

    Report

    Report Number
    1037007-1996-00001
    Event Type
    Injury
    Date Received
    April 26, 1996
    Date of Event
    April 3, 1996
    Report Date
    April 12, 1996
    Manufacturer
    THE MAGSTIM CO, LTD
    Product Code
    JXE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE REMOVAL OF AN ACOUSTIC NEUROMA, THE DEVICE WAS BEING USED AS A MONITOR. THE SURGEON SEVERED THE FACIAL NERVE. IT WAS REPORTED THAT THE DEVICE DID NOT PROVIDE A RESPONSE AT THE TIME THE NERVE WAS SEVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSIGN 100 NERVE MONITOR NERVE STIMULATOR JXE THE MAGSTIM CO, LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability