BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® EMG ELECTRODE

    MDR report key: 6785943 · Received August 10, 2017

    Report

    Report Number
    1045254-2017-00276
    Event Type
    Injury
    Date Received
    August 10, 2017
    Report Date
    July 14, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GXZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LINK TO ARTICLE: HTTPS://LINK.SPRINGER.COM/ARTICLE/10.1007/S00268-015-3368-Y. CONCOMITANT DEVICES: -- UNKNOWN NIM FLEX EMG TUBE -- UNKNOWN NIM RESPONSE 3.0 MAINFRAME -- UNKNOWN NIM RESPONSE 3.0 PATIENT INTERFACE. PRODUCT EVALUATION: ANALYSIS RESULTS ARE NOT AVAILABLE; DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    RESULTS REPORTED IN ¿IMPACT OF EMG CHANGES IN CONTINUOUS VAGAL NERVE MONITORING IN HIGH-RISK ENDOCRINE NECK SURGERY¿, BRAUCKHOF K., ET AL., WORLD J SURG (2016) 40:672¿680. HYPOTHESIS: ¿CONTINUOUS VAGAL INTRAOPERATIVE NEUROMONITORING (CIONM) OF THE RECURRENT LARYNGEAL NERVE (RLN) MAY REDUCE THE RISK OF RLN LESIONS DURING HIGH-RISK ENDOCRINE NECK SURGERY SUCH AS OPERATION FOR LARGE GOITER POTENTIALLY REQUIRING TRANSSTERNAL SURGERY, ADVANCED THYROID CANCER, AND RECURRENCE.¿ THIS ARTICLE WAS CONDUCTED TO EVALUATE WHETHER CONTINUOUS INTRAOPERATIVE NERVE MONITORING WOULD LOWER THE RISK OF RLN LESIONS DURING HIGH-RISK ENDOCRINE NECK SURGERY. THE NIM SYSTEM, EMG TUBE AND APS PROBE WERE USED TO RECORD THE NERVE FUNCTION THROUGHOUT THE PROCEDURES, NOT TO IDENTIFY NERVES. THE LOSS IN AMPLITUDE REPORTED IS A DIAGNOSTIC TOOL USED BY THE SURGEON TO AID IN PREVENTING NERVE INJURY. IF THE AMPLITUDE DROPS BELOW A CERTAIN PERCENT, THE SURGEON KNOWS THAT UNLESS HE MAKES AN ADJUSTMENT, VOCAL CORD INJURY COULD OCCUR. THIS STUDY REPORTS 1 PATIENT WHO SUSTAINED PERMANENT VOCAL CORD PALSY DUE TO AN INTRINSIC ¿ACUTE THERMIC¿ LESION. ¿IN TOTAL, THERE WERE 87 NERVES AT RISK (NAR), 42 ON THE RIGHT AND 45 ON THE LEFT SIDE. LARYNGOSCOPY ON THE FIRST POSTOPERATIVE DAY REVEALED THREE IMMOBILE VOCAL CORDS (3.4 %RELATED TO NAR) IN THREE PATIENTS. TWO WERE NORMAL AFTER 6 MONTHS, RESULTING IN A PERMANENT PALSY RATE OF 1.1 %RELATIVE TO NAR.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565210 NIM® EMG ELECTRODE ELECTRODE, NEEDLE GXZ MEDTRONIC XOMED INC. XOM UNK NIMELECTRO

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Disability