BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® EMG

    MDR report key: 5247402 · Received November 24, 2015

    Report

    Report Number
    1045254-2015-00387
    Event Type
    Injury
    Date Received
    November 24, 2015
    Report Date
    November 2, 2015
    Manufacturer
    MEDTRONICXOMED, INC.
    Product Code
    ETN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4).

    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 IN THE EUROPEAN ANNALS OF OTORHINOLARYNGOLOGY, HEAD AND NECK DISEASES, 131 (2014) 293-297, "THYROID SURGERY IN CHILDREN AND ADOLESCENTS: A SERIES OF 65 CASES". THAT: "THIS WAS A SINGLE-CENTER RETROSPECTIVE STUDY CONDUCTED ON ALL PATIENTS UNDER THE AGE OF 18 YEARS WHO UNDERWENT THYROID SURGERY IN OUR INSTITUTION FROM (B)(6) 2004 TO (B)(6) 2012. SIXTY-FOUR PATIENTS WERE INCLUDED AND A TOTAL OF 65 SURGICAL PROCEDURES WERE PERFORMED." "A SPECIFIC ENDOTRACHEAL TUBE WITH INTEGRATED ELECTRODES (XOMED NIM MONITORING SYSTEM, MEDTRONIC XOMED INSTRUMENTATION) WAS USED IN CHILDREN OVER THE AGE OF 8 YEARS. ONLY ONE CASE OF PERMANENT LEFT RECURRENT LARYNGEAL NERVE PARALYSIS WAS OBSERVED (1.1%) IN A (B)(6) PATIENT UNDERGOING TOTAL THYROIDECTOMY FOR GRAVES' DISEASE, DESPITE INTRAOPERATIVE RECURRENT LARYNGEAL NERVE MONITORING BY ELECTRODES INTEGRATED INTO THE ENDOTRACHEAL TUBE. THE RECURRENT LARYNGEAL NERVE WAS IDENTIFIED AND DID NOT PRESENT ANY PARTICULAR ANATOMICAL VARIANT. IT RESPONDED TO 0.40 MA STIMULATION AT THE BEGINNING OF OPERATION, BUT NO LONGER RESPONDED TO STIMULATION AT THE END OF THE OPERATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777178 NIM® EMG STIMULATOR, NERVE ETN MEDTRONICXOMED, INC. UNKNOWN EMG

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR Disability