BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NERVE STIMULATOR/LOCATOR

    MDR report key: 17433 · Received July 15, 1994

    Report

    Report Number
    17433
    Event Type
    Injury
    Date Received
    July 15, 1994
    Date of Event
    March 23, 1994
    Report Date
    July 15, 1994
    Manufacturer
    BRISTOL-MEYERS SQUIBB COMPANY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OM MARCH, 1994 A SURGICAL PROCEDURE INVOLVING A HAMSTRING LENGTHENING WAS BEING PERFORMED IN WHICH TRHE SURGEON REQUESTED A NERVE STIMULATOR TO IDENTIFY A POSSIBLE NERVE. THE SCRUB NURSE TESTED THE STIMULATOR LIGHT AND IT WORKED. THE SURGEON WAS GIVEN THE STIMULATOR HE CHECKED THE INDICATOR LIGHT AND IT WORKED. THE SURGEON THEN INSERTED THE GROUND NEEDLE INTO THE PT AND APROBED WHAT WAS THOUGHT TO BE A NERVE. THE LIGHT ACTIVATED, BUT A RESPONSE FROM THE PT WAS NOT EVIDENT. THE SURGEON AGAIN FOLLOWED THE SAME PROCEDURE AND AGAIN THE INDICATOR LIGHT CAME ON AND AGAIN NO RESPONSE OCCURRED. AT THIS TIME THE SURGEON CUT THE STRUCTURE (40%). THE SURGEON THEN NOTED THE STRUCTURE APPEARED TO BE A NERVE. HE THEN TESTED THE STRUCTURE WITH A CAUTERY KNIFE AND THIS TIME GOT A NERVE RESPONSE. A SECOND STIMULATOR WAS REQUESTED BY THE SURGEON. THE NERVE WAS TESTED BY THE SECOND STIMULATOR. THE INDICATOR LIGHT CAME ON AND A SLIGHT RESPONSE OCCURRED. THE SURGEON THEN TESTED THE FIRST NERVE STIMULATOR AGAIN. THE INDICATOR LIGHT CAME ON BUT NO RESPONSE OCCURRED. THE NERVE WAS REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NERVE STIMULATOR/LOCATOR SAME BRISTOL-MEYERS SQUIBB COMPANY 85-62010

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention