BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® 3.0 MAINFRAME

    MDR report key: 4418678 · Received January 14, 2015

    Report

    Report Number
    1045254-2015-00014
    Event Type
    Injury
    Date Received
    January 14, 2015
    Date of Event
    November 7, 2014
    Report Date
    December 22, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT - NIM TRIVANTAGE EMG TUBE 6.0MM ID, 510K: K112686 8225101 - 5PK STD PRASS FLUSH TIP PROBE, 510K: K934426. (B)(4). THE PRODUCTS HAVE NOT BEEN RETURNED FOR ANALYSIS. METHOD: 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 THE SURGEON PERFORMED A HEMI-THYROIDECTOMY USING THE NIM-RESPONSE 3.0 MONITOR AND TRIVANTAGE TUBE. THE SURGEON CONFIRMS THAT ALL HAD GREEN CHECKS IN THE SETUP SCREEN. STIMULUS WAS SET BETWEEN 0.8MA AND 1.0MA. EVENT THRESHOLD WAS SET AT THE DEFAULT 100UV. IT IS UNKNOWN WHAT THE STIM RETURN VALUE WAS SHOWING. THE CASE WAS APPROXIMATELY 90 MINUTES LONG. DURING THE OPERATION THE SURGEON DID FIND THE RLN WHICH INITIALLY STIMULATED FINE. LATER IN THE CASE THE NERVE WOULD NOT STIMULATE IN THE SAME AREA. ¿THE ELECTRODES WERE RECOGNIZED [BY THE SYSTEM] AS THERE WERE EVENTS INITIALLY DURING THE CASE. WHEN STIMULATING, SHE INITIALLY RECEIVED BOTH AUDIBLE PULSE RESPONSES AND CORRESPONDING WAVEFORMS. LATER IN THE SURGERY, ON THE SAME SIDE, SHE WOULD RECEIVE AN AUDIBLE PULSE STIMULUS RESPONSE BUT NO WAVEFORMS. VISUAL INSPECTION OF THE NERVE AT THE END OF THE SURGERY SHOWED THE RLN TO BE INTACT. AFTER THE CASE THE SURGEON SCOPED THE PATIENT AND FOUND PARALYSIS OF THE VOCAL CORD. THE SURGEON REPORTED NO CHANGES IN SURGICAL TECHNIQUE, NOR IN NIM SETTINGS. PATIENT HAD TEMPORARY UNILATERAL VOCAL CORD PARALYSIS. PATIENT WENT TO SPEECH THERAPY IMMEDIATELY AND THE VOCAL CORD RECOVERED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34553 NIM® 3.0 MAINFRAME STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 205753295

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention