BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® EMG

    MDR report key: 5413871 · Received February 5, 2016

    Report

    Report Number
    1045254-2016-00031
    Event Type
    Malfunction
    Date Received
    February 5, 2016
    Report Date
    January 12, 2016
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPLICATIONS RELATED TO ELECTRODE PLACEMENT OR USES OF MONITORING TECHNIQUES WERE NOTED. TEMPORARY, MILD MUCOSAL EDEMA OF THE VOCAL CORDS WAS ROUTINELY OBSERVED ON POSTOPERATIVE FLEXIBLE LARYNGOSCOPY. CONCOMITANT MEDICAL PRODUCTS: XOM UNKNOWN NIM (22-GAUGE 1.5-INCH NEEDLE EMG HOOKWIRE ELECTRODES - INTRAMUSCULAR TECHNIQUE): THE PRODUCT NUMBER AND LOT NUMBERS WERE NOT REFERENCED IN THE ARTICLE. THEREFORE, THE MANUFACTURE DATE, USE BY DATE, AND 510K NUMBER CANNOT BE PROVIDED. XOM UNKNOWN NIM (22-GAUGE NEEDLE EMG HOOKWIRE ELECTRODES ¿ PERCUTANEOUS TECHNIQUE): THE PRODUCT NUMBER AND LOT NUMBERS WERE NOT REFERENCED IN THE ARTICLE. THEREFORE, THE MANUFACTURE DATE, USE BY DATE, AND 510K NUMBER CANNOT BE PROVIDED. (B)(4). THE DEVICES WERE NOT RETURNED FOR EVALUATION. THEREFORE, A PRODUCT ANALYSIS HAS NOT BEEN DONE.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FROM THE ARTICLE PUBLISHED IN, ¿THE AMERICAN JOURNAL OF OTOLOGY¿ VOL. 20, NO. 5 IN 1999 ENTITLED, ¿VAGAL NERVE MONITORING IN SURGERY OF THE SKULL BASE: A COMPARISON OF EFFICACY OF THREE TECHNIQUES¿ BY LANCE E. JACKSON AND JOSEPH B. ROBERSON, JR. THE ARTICLE INDICATES THAT DURING A 1-YEAR PERIOD FROM JUNE 1997 TO MAY 1998, 17 PATIENTS WERE ENTERED IN THE STUDY THAT WERE TO UNDERGO SURGERY, DURING WHICH, IT WAS ANTICIPATED THE VAGAL NERVE WOULD BE WITHIN THE SURGICAL FIELD AND POSSIBLY PLACED AT RISK. THE STUDY OBJECTIVE WAS TO COMPARE THREE TECHNIQUES OF MONITORING THE VAGAL NERVE DURING SKULL BASE SURGERY USING LARYNGEAL ELECTROMYOGRAPHY (EMG). THE NIM EMG ENDOTRACHEAL TUBE (ETT), 22-GUAGE 1.5-INCH NEEDLE HOUSING PAIRED EMG HOOKWIRE ELECTRODES USED FOR THE ENDOSCOPICALLY PLACED INTRAMUSCULAR TECHNIQUE, AND 22-GUAGE NEEDLE HOUSING PAIRED EMG HOOKWIRE ELECTRODES USED FOR THE PERCUTANEOUS TECHNIQUE WERE AMONG THE DEVICES USED IN THE STUDY. ABSENT RESPONSES (FALSE NEGATIVES) FOR EACH MONITORING METHOD WERE NOTED. AT TIMES, WHEN RESPONSES WERE OBTAINED FROM TWO OBVIOUSLY FUNCTIONING ELECTRODE TECHNIQUES AND A THIRD FAILED TO RESPOND, THE NONRESPONSIVE TECHNIQUE WAS NOTED. AFTER SURGERY, ALL PATIENTS WERE NOTED TO HAVE NORMAL VOCAL CORD FUNCTION WITH ABSENCE OF SYMPTOMS OF HOARSENESS, DYSPHAGIA, AND AS PIRATION, WHICH COULD INDICATE VAGAL NERVE COMPROMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71237 NIM® EMG STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. XOM UNKNOWN EMG

    Patients

    Seq Age Sex Outcome Treatment
    1