BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEUOSIGN 100

    MDR report key: 242594 · Received September 22, 1999

    Report

    Report Number
    8021774-1999-00002
    Event Type
    Other
    Date Received
    September 22, 1999
    Date of Event
    June 22, 1999
    Report Date
    September 14, 1999
    Manufacturer
    THE MAGSTIM CO LIMITED
    Product Code
    JXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE ELECTRODES ATTACHED TO THE PT BECAME DISCONNECTED FROM THE PT. THE NEUROSIGN 100 DEVICE FAILED TO ALARM INDICATING THE DISCONNECTION OF THE ELECTRODES. NO SOUND (BEEPS) AND NO RED LIGHT INDICATOR. THE FACIAL NERVE WAS CUT AND THEN REPAIRED AFTER THE REMOVAL OF THE TUMOR AND THE INFECTION. UNIT WAS EVALUATED AT SMITH & NEPHEW INC ENT DIV, AND NO PROBLEMS WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUOSIGN 100 NERVE MONITOR JXE THE MAGSTIM CO LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1