BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE NEUROLOGICAL WORKSTATION

    MDR report key: 1909025 · Received November 29, 2010

    Report

    Report Number
    2434986-2010-00001
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    January 5, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AXON SYSTEMS, INC.
    Product Code
    GWF
    PMA / PMN Number
    K050798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A LETTER WAS RECEIVED FROM FDA, DATED OCTOBER 15, 2010, REQUEST FOR ADDITIONAL INFO ON 10/22/2010.

    Description of Event or Problem · 1

    AS PREVIOUSLY REPORTED IN DETAIL IN MAUDE REPORT (B)(4). IN 2010, FEMALE PT UNDERWENT TOTAL POSTERIOR CERVICAL 6-7 DISC REPLACEMENT WITH FUSION. THE AXON DAQ916 DIGITAL PREAMPLIFIER BOX WAS PLACED NEXT TO THE PT'S NECK. THE NEUROTECHNICIAN COULD NOT VISUALIZE THE BOX AS THE MD WAS STANDING BETWEEN HIM AND THE PT. THE AXON EEX901 ELECTRICAL STIMULATOR, ALL APPEARED TO BE FUNCTIONING WITHOUT ISSUE. DURING THE IRRIGATION, OF THE WOUND NEAR THE END OF THE PROCEDURE, SOME OF THE FLUIDS SPLASHED INTO THE PREAMPLIFIER BOX, WHEN THE DRAPES WERE PULLED AWAY FROM THE PT AND AS THE NEURO-MONITORING TECH WAS REMOVING THE NEEDLE ELECTRODES CONNECTED TO THE NEURO-TRANSMITTER, HE NOTED 8 SMALL CIGARETTE SIZE BURNS (0.5MM DIAMETER DARKENED AREAS) AT THE NEEDLE SITES. ON 11/18/2010, AXON SYSTEMS, INC. LEARNED THAT AFTER THE EVENT OF (B)(6) 2010, THE PT UNDERWENT AN MRI AND MADE 3 VISITS AT (B)(6) HOSPITAL WOUND CARE CLINIC FOR FOLLOW-UP ON HER BURNS. AFTER THE 3RD VISIT: LATERAL ARM SCARS WERE SLIGHTLY HYPERTOPIC WITH AREAS OF ESCHAR NOTED ON TOP. SOME FAIRLY FLUSH, DISCOLORED, BUT HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE NEUROLOGICAL WORKSTATION ECLIPSE SYSTEM GWF AXON SYSTEMS, INC. ECLC16P

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other| R