BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSIGN 100

    MDR report key: 239336 · Received August 12, 1999

    Report

    Report Number
    1037007-1999-00003
    Event Type
    Injury
    Date Received
    August 12, 1999
    Date of Event
    June 22, 1999
    Report Date
    August 12, 1999
    Manufacturer
    MAGSTIM CO. LTD.
    Product Code
    JXE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSIGN 100 NERVE MONITOR JXE MAGSTIM CO. LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention