BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE 8229306 NIM EMG 6MM RE

    MDR report key: 3105211 · Received May 10, 2013

    Report

    Report Number
    1045254-2013-00367
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCTS: 8253001, MAINFRAME NIM RESPONSE 3.0, S/N (B)(4), LOT 68852600 ETN MANUFACTURED AUGUST 3, 2010, 510K: K083124; 8253200, PATIENT INTERFACE RESPONSE 3.0, S/N/LOT NOT PROVIDED, ETN, 510K: K083124; (B)(4). EVALUATION SUMMARY: NO EVALUATION WAS DONE, THE DEVICE WAS NOT RETURNED FOR ANALYSIS; IT WAS DISCARDED BY THE FACILITY; HOWEVER, THE AVAILABLE INFORMATION INDICATES THAT THIS EVENT MOST LIKELY OCCURRED BECAUSE OF AN INTERACTION BETWEEN THIS DEVICE AND ANOTHER ELECTRONIC STIMULATING DEVICE THAT WAS BEING USED DURING THE PROCEDURE. METHOD CODE: NO TESTING METHODS PERFORMED. (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 THAT A NIM 3.0 RESPONSE AND REINFORCED EMG TUBE WERE BEING USED AS WELL AS A SEPARATE ANESTHESIOLOGY MONITOR WITH A TRANSCUTANEOUS FACIAL NERVE STIMULATOR THAT IS USED FOR MONITORING THE DEGREE OF MUSCLE PARALYSIS DURING SURGERY. THE SURGEON WAS PERFORMING A THYROIDECTOMY USING THE NIM RESPONSE 3.0 WITH A REINFORCED EMG TUBE. THE SURGEON OBSERVED THAT THE PATIENT HAD BILATERAL LARYNGEAL RECRUITMENT THAT APPEARED TO BE IN-SYNC WITH THE USE OF THE ANESTHESIOLOGIST'S TRAIN-OF-FOUR TRANSCUTANEOUS STIMULATOR. THE ANESTHESIOLOGIST'S TRANSCUTANEOUS STIMULATOR WAS SET TO 40MA WITH A RATE OF APPROXIMATELY ONCE PER SECOND. IT APPEARED TO THE SURGEON THAT THE EMG TUBE WAS COUPLING THE TRANSCUTANEOUS STIMULATION SIGNAL DOWN TO THE LARYNX CAUSING BILATERAL LARYNGEAL RECRUITMENT. THIS CONTINUED FOR ABOUT 10 MINUTES. THIS PATIENT EXHIBITED FLACCID PARALYSIS OF THE VOCAL FOLDS IN RECOVERY (WEAKNESS). PATIENT COULD STILL BREATHE AND SWALLOW. IT WAS CONFIRMED THROUGH THE PHYSICIAN THAT THE PATIENT HAS EXPERIENCE A RELATIVELY RAPID RECOVERY OF LARYNGEAL ABDUCTION SINCE THE PROCEDURE. BOTH VOCAL CORDS ARE NOW ABDUCTING NORMALLY WITH RESPIRATION WHEREAS, ACUTELY THERE WAS NOT ACTIVE ABDUCTION WITH THE RIGHT VOCAL CORD MIDLINE AND THE LEFT VOCAL CORD IN A PARAMEDIAN POSITION. AS OF POST-OPERATIVE DAY SIX, SHE HAS BEGUN TO REESTABLISH ADDUCTION OF THE RIGHT VOCAL CORD. THIS IS THE FIRST EVIDENCE OF ADDUCTION ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207051 ENDOTRACHEAL TUBE 8229306 NIM EMG 6MM RE STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8229306 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention