BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSIGN 100 NERVE MONITOR

    MDR report key: 110618 · Received July 29, 1997

    Report

    Report Number
    8021774-1997-00001
    Event Type
    Injury
    Date Received
    July 29, 1997
    Date of Event
    August 1, 1996
    Report Date
    July 29, 1997
    Manufacturer
    THE MAGSTIM COMPANY LTD.
    Product Code
    JXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRE-AMPLIFIER UNIT WAS RETURNED TO THE MFR, CONNECTOR FOUND TO BE BROKEN AND HELD TOGETHER WITH SURGICAL TAPE. ON INVESTIGATION A CORE OF THE PRE-AMPLIFIER CABLE WAS FOUND TO HAVE BEEN SEVERED WITHIN THE CONNECTOR, ALLOWING THE INPUTS OF THE PRE-AMPLIFIER TO FLOAT AT SUPPLY RAIL VOLTAGE. THIS PERMITTED A DC CURRENT OF APPROX. 0.7MA TO FLOW WHICH THEN CAUSED THE BURN NOTED BY DR. CORRECTIVE ACTION WAS TAKEN AS FOLLOWS: THE INPUT CIRCUIT WAS REVISED TO PREVENT RECURRENCE IN THE EVENT OF CABLE DAMAGE, AND A ROLLING PROGRAMME INSTITUTED TO UPGRADE ALL EXISTING PRE-AMPLIFIERS IN THE U.S.A.

    Description of Event or Problem · 1

    DURING SURGERY WHICH UTILISED A NEUROSIGN 100 WITH TWO ELECTROCAUTERY UNITS, THE PT RECEIVED RF (RADIO FREQUENCEY) BURNS AT THE SITE OF THE NEUROSIGN ELECTRDES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention