BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM-ECLIPSE SPINAL SYSTEM

    MDR report key: 2800877 · Received September 20, 2012

    Report

    Report Number
    2800877
    Event Type
    Injury
    Date Received
    September 20, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 20, 2012
    Manufacturer
    AXON SYSTEMS, INC.
    Product Code
    GWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    THE TECH FROM A CONTRACTED INTRAOPERATIVE NEUROMONITORING COMPANY PLACED THE 45 NEEDLE ELECTRODES AND PERFORMED THE NEUROMONITORING OF THE PATIENT DURING THE PROCEDURE. AT THE CONCLUSION OF THE SURGERY, THE ELECTRODE NEEDLES WERE REMOVED, AND IT WAS NOTED THAT THERE WERE BLACKENED CIRCULAR AREAS ABOUT 3MM IN DIAMETER AT EVERY NEEDLE SITE. IT IS UNKNOWN IF THE AREAS WERE ELECTRICAL BURNS OR TISSUE NECROSIS. THERE WERE MULTIPLE CIRCULAR BURN MARKS TO PATIENT'S BILATERAL LOWER EXTREMITIES AND LOWER ABDOMEN FROM THE NEUROSTIMULATOR. THE PLANTAR SURFACE OF THE LEFT FOOT DID HAVE A LARGE BLOOD BLISTER TYPE APPEARANCE FROM THE MONITORING LEAD. THIS WAS THEN ROOFED AND THEN COPIOUSLY IRRIGATED AND SUCTIONED DRY AND DRESSED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIM-ECLIPSE SPINAL SYSTEM EQUIPMENT, PHOTOGRAPHIC, FOR PHYSIOLOGIC FUNCTION MONITOR GWF AXON SYSTEMS, INC. * *
    2 NIM ECLIPSE ELECTRODES CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING GWF AXON SYSTEMS * 945DSN1260

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| O| R