BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM ECLIPSE

    MDR report key: 2446862 · Received February 12, 2012

    Report

    Report Number
    1045254-2012-00018
    Event Type
    Injury
    Date Received
    February 12, 2012
    Date of Event
    January 13, 2012
    Report Date
    January 17, 2012
    Manufacturer
    MEDTRONIC XOMED MFG, INC.
    Product Code
    GWF
    PMA / PMN Number
    K050798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED. NEITHER APPLICABLE IMAGING FILMS NOR MEDICAL RECORDS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. REPORT INCONCLUSIVE. NO EVALUATION WAS PERFORMED, AS THE DEVICE WAS NOT RETURNED. IF THE DEVICE IS RETURNED IN THE FUTURE, PRODUCT ANALYSIS WILL BE PERFORMED. THE AVAILABLE INFORMATION REASONABLY SUGGESTS THAT A DEVICE IN QUESTION WAS IN USE WHEN AN ADVERSE EVENT OCCURRED AND A REVIEW OF THE COMPLAINT HISTORY INDICATES THAT USE OF THIS PRODUCT HAS RESULTED IN AN ADVERSE EVENT IN THE PAST. THEREFORE IT IS LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF THIS EVENT WERE TO RECUR. WITHOUT PRODUCT RETURN, IT COULD NOT BE DETERMINED IF THE PRODUCT WAS IN SPECIFICATION. THE AXON NIM (NERVE INTEGRITY MONITOR)-ECLIPSE SYSTEM IS A POWERFUL, MULTI-FUNCTIONAL NEUROVASCULAR MONITOR DESIGNED FOR INTRAOPERATIVE AND ICU APPLICATIONS. THE SYSTEM CAN BE USED TO SIMULTANEOUSLY MONITOR EEG, EVOKED POTENTIALS (EP) AND SPONTANEOUS AND TRIGGERED EMG ACTIVITY. IT IS DESIGNED TO MEET THE HIGHLY DEMANDING REQUIREMENTS FOR COMPREHENSIVE NEUROLOGICAL MONITORING IN THE ELECTRICALLY HOSTILE OPERATING ROOM AND CRITICAL CARE ENVIRONMENT. THE SYSTEM INCORPORATES A GRAPHICAL, POINT AND SHOOT STYLE, USER INTERFACE TO CLEARLY IDENTIFY AND SPEED PARAMETER SELECTION. A/D CONVERSION IS PERFORMED IN THE DIGITAL PREAMPLIFIER MODULE, AT THE PATIENT LOCATION, TO MINIMIZE INTERFERENCE AND IMPROVE ISOLATION. HIGH PERFORMANCE PREAMPLIFIERS, COMBINED WITH DIGITAL SIGNAL PROCESSING AND STATISTICAL TESTING ARE USED TO INSURE HIGH QUALITY RECORDED DATA. THE SYSTEM INCORPORATES MULTIPLE DIGITAL SIGNAL PROCESSORS AND MICROCONTROLLERS TO ENHANCE PRODUCT FLEXIBILITY, RESPONSE TIME, AND PATIENT SAFETY. ALL PATIENT CONNECTIONS ARE BOTH SOFTWARE AND HARDWARE PROTECTED AGAINST FAULTS. PATIENT DATA CAN BE REVIEWED WHILE MONITORING IS IN PROGRESS. DATA FROM TWO PATIENTS MAY BE REVIEWED SIMULTANEOUSLY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED SPINE SURGERY WITH INTRA-OPERATIVE MONITORING FOR RESECTION OF A VERTEBRAL BODY WITH SCREW REVISION. NO MOTOR EVOKED POTENTIALS WERE MONITORED, ONLY EMG AND SCREW TESTING BECAUSE THE DOCTOR DID NOT HAVE THE INFORMED CONSENT TO INCLUDE THE ELECTRODE SETTINGS AT THE HEAD. THIS WAS DISCUSSED PRE-OPERATIVELY WITH THE SURGEON AND MONITORING TECHNICIAN. POSTOPERATIVELY THE PATIENT EXPERIENCED NO LEG MOVEMENT WITH POSSIBLE PARTIAL PARAPLEGIA. NO FURTHER FOLLOW-UP OF THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIM ECLIPSE STIMULATOR, NERVE, AC-POWERED GWF MEDTRONIC XOMED MFG, INC. 945NES32P UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability