BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM RESPONSE® NERVE MONITORING SYSTEM

    MDR report key: 4210918 · Received October 29, 2014

    Report

    Report Number
    1045254-2014-00278
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE PRODUCTS HAVE NOT BEEN RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    USING A TRIVANTAGE TUBE DURING A GLAND REMOVAL, THE SURGEON WAS STIMULATING WHAT HE THOUGHT WAS THE NERVE BUT WOULD NOT GET ANY RESPONSES. AT THE END OF THE CASE, HE STIMULATED IN MULTIPLE AREAS AND WAS GETTING FALSE RESPONSES. THE SURGEON THOUGHT THE NERVE MAY HAVE BEEN DAMAGED AND SUBSEQUENTLY REPAIRED IT. THE BIOMED DEPARTMENT DETERMINED THAT THE STIM 1 FUSE WAS BLOWN. THIS WOULD HAVE PREVENTED THE SYSTEM FROM DELIVERING STIMULATION TO THE PATIENT AND THUS NO EMG RESPONSE WOULD BE GENERATED. THE USERS BELIEVE THAT SINCE THEY WERE NOT ABLE TO MONITOR APPROPRIATELY, THAT THIS IS THE REASON THE PATIENT'S NERVE WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694114 NIM RESPONSE® NERVE MONITORING SYSTEM STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 68876700

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ENT EMG/LASER PART # UNKNOWN