BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® EMG

    MDR report key: 5697532 · Received June 3, 2016

    Report

    Report Number
    1045254-2016-00173
    Event Type
    Injury
    Date Received
    June 3, 2016
    Report Date
    May 9, 2016
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    ETN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: ANALYSIS RESULTS NOT AVAILABLE; NO DEVICES WERE RETURNED FOR EVALUATION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 ARTICLE, ¿CLINICAL VALUE OF INTRAOPERATIVE NEUROMONITORING OF THE RECURRENT LARYNGEAL NERVES IN IMPROVING OUTCOMES OF SURGERY FOR WELL-DIFFERENTIATED THYROID CANCER¿, POLISH REVIEW OF SURGICAL 10.2478 / V10035-011-0030-8 2011, 83, 4, 196-203: ¿THE AIM OF THE STUDY WAS TO VERIFY THE HYPOTHESIS THAT METICULOUS SURGICAL TECHNIQUE OF TISSUE DISSECTION IN THE AREA OF THE POSTERIOR SURFACE OF THE THYROID CAPSULE AND ADJACENT RLN MAY BE ADDITIONALLY FACILITATED BY INTRAOPERATIVE NEUROMONITORING (IONM), AND MAY CONTRIBUTE TO INCREASING THE SAFETY AND RADICALNESS OF TOTAL THYROIDECTOMY IN PATIENTS WITH WELL-DIFFERENTIATED THYROID CANCER.¿ ¿MATERIALS AND METHODS: IN THIS STUDY PROSPECTIVELY COLLECTED DATA IN THE DEPARTMENT¿S REGISTER OF THYROID SURGERY WERE ANALYZED. THE AUTHORS COMPARED THE RESULTS OF TOTAL EXTRACAPSULAR THYROIDECTOMIES WITH LEVEL VI LYMPH NODE CLEARANCE FOR WELL DIFFERENTIATED THYROID CANCER (WDTC; PT1-3-,N0-1,MX) IN TWO GROUPS OF PATIENTS: 151 PATIENTS OPERATED ON WITH IONM (BETWEEN JANUARY 2005 AND JUNE 2009) AND 151 PATIENTS OPERATED ON WITHOUT IONM (BETWEEN JANUARY 2003 AND DECEMBER 2004).¿ IN THE GROUP OF PATIENTS OPERATED ON WITH IONM, THE AUTHORS EMPLOYED A NIM2.0 UNIT (MEDTRONIC, (B)(4)) WITH SURFACE ELECTRODES INTEGRATED WITH INTUBATION TUBE FOR 39 PROCEDURES.¿ ¿RESULTS: AMONG PATIENTS OPERATED WITH VS. WITHOUT IONM, THE EARLY RLN INJURY RATE WAS 3% VS. 6.7% (P=0.02), INCLUDING 2% VS. 5% (P=0.04) OF TEMPORARY NERVE LESIONS, AND 1% VS. 1.7% OF PERMANENT NERVE EVENTS (P=0.31), RESPECTIVELY. EXTRALARYNGEAL RLN BIFURCATION WAS IDENTIFIED IN 42 (27.8%) VS. 25 (16.6%) OF PATIENTS OPERATED WITH VS. WITHOUT IONM, RESPECTIVELY (P=0.001). MEAN I-131 UPTAKE FOLLOWING TOTAL THYROIDECTOMY WITH VS. WITHOUT IONM WAS 0.67 ± 0.39% VS. 1.59 ± 0.69% (P<(><<)>0.001). I-131 UPTAKE LOWER THAN 1% WAS FOUND IN 106 (70.2%) VS. 38 (25.2%) PATIENTS OPERATED WITH VS. WITHOUT IONM, RESPECTIVELY (P<(><<)>0.001).¿ ¿IN THE PRESENTED STUDY, THE USE OF IONM ALLOWED FOR DECREASING THE RISK OF RLN INJURY BY 3.7% (P =0.04), INCLUDING A 3% DROP IN THE RISK OF TRANSIENT (P =0.02) AND A 0.7% DROP IN THE RISK OF PERMANENT DAMAGE (P =0.31). WHAT IS MOST IMPORTANT, THE IMPROVEMENT OF THESE OUTCOMES WAS ACCOMPANIED BY A SIGNIFICANT INCREASE OF RADICALNESS OF THYROID TISSUE RESECTION IN THE GROUP OPERATED ON WITH IONM AS ASSESSED BY POSTOPERATIVE I-131 UPTAKE (BY THE MEAN VALUE OF 0.92%), AND THE PERCENTAGE OF PATIENT WITH IODINE UPTAKE BELOW 1% INCREASED WHEN IONM WAS EMPLOYED BY AS MUCH AS 45%.¿ ¿NEUROMONITORING INCREASES THE ACCURACY OF MACROSCOPIC IDENTIFICATION OF ANATOMICAL VARIANTS OF BIFURCATED RLNS AND ALLOWS FOR DECREASING ¿UNDUE TRACTION¿ INJURIES, THUS PREVENTING NEUROPRAXIA OF THE ANTERIOR BRANCH OF THE BIFURCATED RECURRENT LARYNGEAL NERVE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351179 NIM® EMG STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC UNKNOWN EMG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other