BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

    MDR report key: 5765681 · Received July 1, 2016

    Report

    Report Number
    1045254-2016-00217
    Event Type
    Injury
    Date Received
    July 1, 2016
    Date of Event
    June 3, 2016
    Report Date
    June 6, 2016
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    ETN
    PMA / PMN Number
    K112686
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: STIMULATOR PROBE 8225101, THE 510K: K934426 NIM 3.0 MAINFRAME, SERIAL # (B)(4), LOT # 68604300 THE FACILITY SUBMITTED MEDWATCH (B)(4). TRIVANTAGE TUBE 9229707 UNDERWENT EXTENSIVE ANALYSIS. UPON RECEIPT, IT WAS NOTED THAT THE WIRES WERE CUT. IT WAS CONFIRMED WITH THE CUSTOMER THAT THE WIRES WERE CUT BY THE ANESTHESIA TEAM. WIRES WERE SOLDERED BACK TOGETHER FOR ANALYSIS PURPOSES. RESISTANCE WAS MEASURED FROM ALL 4 WIRES TO ITS CORRESPONDING ELECTRODE. ALL MEASUREMENTS WERE LESS THAN 20 OHMS. THE TRIVANTAGE DEVICE WAS TESTED USING A NIM AND THE ANALYST COULD NOT REPLICATE THE FAILURE MODE. THE ANALYSIS FOR STIMULATOR PROBE 8225101 HAS NOT BEEN PERFORMED AT THIS TIME, BUT IS EXPECTED. THE NIM 3.0 MAINFRAME HAS NOT BEEN RETURNED FOR ANALYSIS PER THE FACILITY'S PREFERENCE. 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

    THE CONCOMITANT DEVICE, A PRASS STIMULATING PROBE, WAS EVALUATED. THE MEASURED ELECTRICAL RESISTANCE FROM THE TIP OF THE PROBE TO THE CONNECTOR WAS BELOW 10 OHMS, WHICH WAS WITHIN SPECIFICATION. THE PROBE WAS CONNECTED TO A NIM 3.0 SYSTEM AND DEMONSTRATED NO ISSUES DELIVERING THE SET CURRENT FROM THE NIM TO THE TIP OF THE PROBE. THEREFORE, NO FAULT WAS FOUND WITH THIS CONCOMITANT DEVICE.

    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 DURING RIGHT THYROID LOBECTOMY AND PARATHYROID AUTOTRANSPLANTATION USING INTRAOPERATIVE NERVE MONITORING (IONM), THE SURGEON DISSECTED TO THE SUPERIOR PARATHYROID. HERE A WHITE STRUCTURE PASSED JUST ANTERIORLY TO THE SUPERIOR PARATHYROID AND APPEARED TO BE A LIKELY CANDIDATE FOR THE RLN. THE NERVE MONITOR PROBE WAS USED TO STIMULATE TISSUE ADJACENT TO THIS STRUCTURE AND GAVE WHAT THE PHYSICIAN INTERPRETED AS AN APPROPRIATELY NEGATIVE RESPONSE, BASED ON THE NIM MAINFRAME'S AUDIBLE OUTPUT. STIM OUTPUT WAS SET AT 1 MA WITH THRESHOLD AT 100. THE PUTATIVE NERVE WAS THEN TESTED AND DEMONSTRATED A POSITIVE SIGNAL SHOWING CONDUCTION THROUGH THE RLN, BASED ON PHYSICIAN INTERPRETATION OF AUDIBLE OUTPUT. THE PHYSICIAN INDICATES THAT NO PHYSICAL RESPONSE TO STIMULUS WAS SEEN, NOR WOULD IT BE EXPECTED. DISSECTION PROCEEDED WITH LIGATION OF MULTIPLE BRANCHES OF THE INFERIOR THYROID ARTERY. AS DISSECTION CONTINUED ALONG THE PREVIOUSLY IDENTIFIED STRUCTURE, IT BECAME OBVIOUS THAT THIS STRUCTURE WAS NOT IN FACT THE RLN. THEY PHYSICIAN STATES THAT IN HINDSIGHT, IT APPEARED TO BE JUST FIBROUS TISSUE. THE RLN WAS THEN IDENTIFIED AS IT ENTERED INTO THE LARYNX. THIS WAS FOLLOWED PROXIMALLY TO A POINT WHERE IT WAS CLEAR THAT THE NERVE HAD BEEN PREVIOUSLY DIVIDED DURING LIGATION OR INFERIOR THYROID ARTERY BRANCHES. AT THIS TIME THE SURGEON AGAIN UTILIZED THE NERVE MONITOR WHICH CONTINUED TO GIVE THE SAME SIGNAL, PREVIOUSLY ASSUMED TO BE POSITIVE FOR NERVE RESPONSE, EVERYWHERE IN THE NECK, INCLUDING MUSCLE, THE JUGULAR VEIN, THE STRAP MUSCLE, AND EVEN THE EXTERNAL SKIN. THUS, THE SURGEON CONCLUDED THAT THE DEVICE GAVE FALSE POSITIVE RESPONSES. WHEN THE SALES REP VISITED ON A LATER DATE, IT WAS DETERMINED THAT THE SIGNALS INTERPRETED AS "FALSE POSITIVES" WERE STIMULUS ARTIFACT. THIS WAS EVIDENCED BY THE MINIMAL ELECTRICAL STIMULUS RETURN (APPROXIMATELY 102 MICROVOLTS, ORIGINATING OFF-SCREEN DUE TO THE SCATTERED ELECTRICAL STIMULATION ONLY MILDLY SURPASSING THE THRESHOLD) IN COMPARISON TO WHAT IS EXPECTED AND WHAT WAS SEEN IN A TRUE POSITIVE RESPONSE (APPROXIMATELY 200+ MICROVOLTS, ORIGINATING ON-SCREEN DUE TO THE EVEN ORIGINATING FROM ACTUAL DIRECT NERVE CONDUCTION AND CLEARLY EXCEEDING THE THRESHOLD). NEVERTHELESS, THE PHYSICIAN INDICATES THAT THE AUDIBLE RESPONSE FROM THE UNIT INDICATED A POSITIVE RESPONSE. THE PATIENT'S SEVERED RIGHT RECURRENT LARYNGEAL NERVE WAS REPAIRED, AND THE PATIENT IS EXPECTED TO EXPERIENCE PERMANENT VOCAL HOARSENESS. THERE WAS NO OTHER INJURY OR UNEXPECTED MEDICAL INTERVENTION REQUIRED FOR THE PATIENT. SINCE THIS EVENT, THE REP VISITED THE SITE TO COLLECT DISPOSABLE DEVICES, AND CHECK THE NIM MAINFRAME ALONG WITH THE FACILITY'S BIOMEDICAL ENGINEERS. THERE WAS NO ISSUE FOUND WITH THE MAINFRAME. THE REP DID UPGRADE THE NIM SOFTWARE TO THE LATEST VERSION DURING HIS VISIT, AND PROVIDED INSERVICE TO THE MEDICAL TEAM. FDA VOLUNTARY MEDWATCH (B)(4) WAS FILED BY (B)(6) IN THE UNC RISK MANAGEMENT DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419508 NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE® STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC 8229707 0211210477

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention