BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBDURAL NEEDLE ELECTRODE

    MDR report key: 32193 · Received March 11, 1996

    Report

    Report Number
    32193
    Event Type
    Injury
    Date Received
    March 11, 1996
    Date of Event
    February 23, 1996
    Report Date
    February 28, 1996
    Manufacturer
    ASTRO-MED, INC.
    Product Code
    GXZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE NEURO MONITORING TECH HAD 48 INCHES OF ONE OF HER ELECTRODE LEADS BREAK OFF INTO THE PT'S RIGHT POPLITEAL AREA, C-ARM WAS USED. SEARCHED FOR THE ELECTRODE. A SMALL SKIN INCISION WAS MADE, THE NEEDLE ELECTRODE WAS NEVER RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBDURAL NEEDLE ELECTRODE NEEDLE ELECTRODE GXZ ASTRO-MED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention