BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSIGN 100 NERVE MONITOR

    MDR report key: 36179 · Received August 22, 1996

    Report

    Report Number
    1037007-1996-00002
    Event Type
    Injury
    Date Received
    August 22, 1996
    Report Date
    August 21, 1996
    Manufacturer
    THE MAGSTIM CO LTD
    Product Code
    JXE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY WHICH UTILIZED A DEVICE WITH TWO OTHER ELECTROCAUTERY UNITS, THE PT RECEIVED RF (RADIO FREQUENCY) BURNS AT THE SITE OF THE ELECTRODES. IT IS NOT KNOWN AT THIS TIME IF THE DEVICE CONTRIBUTED TO THE EVENT. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.

    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 * Required Intervention