BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® EMG

    MDR report key: 5267379 · Received December 4, 2015

    Report

    Report Number
    1045254-2015-00407
    Event Type
    Injury
    Date Received
    December 4, 2015
    Report Date
    November 9, 2015
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THIS INFORMATION IS BEING REPORTED FROM A LITERATURE REVIEW. NO DEVICES WILL BE RETURNED. THEREFORE, AN EVALUATION WILL NOT BE PERFORMED. BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE ARTICLE, "INTRAOPERATIVE RECURRENT LARYNGEAL NERVE MONITORING IN THYROID SURGERY: IS IT REALLY USEFUL?" BY P.G. CALO, G. PISANO, F. MEDAS, A. TATTI, M.R. PITTAU, R. DEMONTIS, P. FAVORITI, AND A. NICOLOSI, EVALUATES THE ABILITY OF INTRAOPERATIVE RECURRENT LARYNGEAL NERVE MONITORING TO PREDICT THE POSTOPERATIVE FUNCTIONAL OUTCOME AND THE ROLE MONITORING MAY PLAY IN REDUCING POSTOPERATIVE NERVE PALSY. BETWEEN JUNE 2007 AND DECEMBER 2011, 751 PATIENTS WERE STUDIED THAT UNDERWENT VARIOUS TYPES OF THYROID SURGERY USING THE NIM SYSTEM. THE ARTICLE INDICATES THAT THERE WERE 19 UNILATERAL RECURRENT LARYNGEAL NERVE PARALYSES, 13 OF WHICH WERE TRANSIENTS, AND 6 WERE PERMANENTLY DAMAGED. ONE PATIENT EXPERIENCED A BILATERAL RECURRENT LARYNGEAL PALSY, WHICH REQUIRED A TRACHEOSTOMY. IN TOTAL, THERE WERE 20 RECURRENT LARYNGEAL NERVE INJURIES. OF THE 20 CASES, THERE WERE 14 TRANSIENT CASES AND 6 PERMANENT CASES. THERE WERE 6 NIM FALSE POSITIVES AND 2 FALSE NEGATIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798805 NIM® EMG STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. XOM UNKNOWN EMG

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability