BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NICOLET

    MDR report key: 66317 · Received September 24, 1996

    Report

    Report Number
    66317
    Event Type
    Injury
    Date Received
    September 24, 1996
    Date of Event
    September 17, 1996
    Report Date
    September 24, 1996
    Manufacturer
    NICOLET
    Product Code
    GXZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS STATUS SURGICAL INTERVENTION FOR ANTERIOR CERVICAL DISCECTOMY WITH FUSION AND STABILIZATION. AFTER BEING ANESTHETISIZED, APPLICATION OF SUBDERMAL ELECTRODES WAS IN PROCESS BY NEURODIAGNOSTIC TECHNICIAN. THE NEEDLE ELECTRODE WAS INSERTED, COILED AND TAPED TO BE SECURED TO PT'S RIGHT WRIST WHEN IT BECAME DETACHED FROM THE WIRE. THE NEUROSURGEON, WITH THE USE OF THE "C" ARM REMOVED THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NICOLET SUBDERMAL NEEDLE ELECTRODE GXZ NICOLET 019-738100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention