BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NICOLET SUBDERMAL NEEDLE

    MDR report key: 35467 · Received June 28, 1996

    Report

    Report Number
    35467
    Event Type
    Malfunction
    Date Received
    June 28, 1996
    Date of Event
    February 20, 1996
    Report Date
    March 4, 1996
    Manufacturer
    NICOLET BIOMEDICAL, INC.
    Product Code
    GXE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 2/20/96 PT UNDERGOING POSTERIOR LUMBARSPINE DECOMPRESSION, FUSION AND INSTRUMENTATION HAD A STERILE SUBDERMAL RECORDING ELECTRODE PLACED IN THE LEFT VASTUS LATERALIS MUSCLE BY THE SPINE FELLOW. LARGE AMOUNTS OF ELECTRICAL NOISE PROMPTED THE NEUROPHYSIOLOGY TECHNOLOGIST TO CHECK THE SITE. THE NEEDLE HAD SEPARATED FROM SITE. THE NEEDLE HAD SEPARATED FROM THE WIRE. NEEDLE WAS VISUALIZED ON SUBSEQUENT AP & LATERAL FILMS. FOLLOWING COMPLETION OF THE CASE AN UNSUCCESSFUL ATTEMPT WAS MADE TO REMOVE THE NEEDLE FROM THE MUSCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NICOLET SUBDERMAL NEEDLE SUBDERMAL NEEDLE GXE NICOLET BIOMEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other 2.5 MM CABLE