BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® EMG

    MDR report key: 24330549 · Received February 13, 2026

    Report

    Report Number
    1045254-2026-00208
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    January 21, 2026
    Report Date
    April 1, 2026
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E: CORRECTION HAS BEEN UPDATED. H6: ADDITIONAL CODE IMF F1908 IS APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H6: THE PREVIOUSLY APPLIED FDM B17 AND FDC D16 ARE NO LONGER APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTRAOPERATIVELY, THEY, WERE DOING MONITORING WITH THE NIM VITAL DEVICE FROM BOTH SIDES. EVERYTHING WAS FINE ON THE RIGHT SIDE (GREAT RESPONSE FROM THE LRN AND VAGUS); THEY THEN STARTED THE OTHER SIDE AND OBTAINED ONE RESPONSE FROM THE LEFT LRN AND EVENTUALLY LOST THE SIGNAL FROM THAT SIDE AND NEVER RECOVERED. THE TROUBLESHOOTING PERFORMED WAS FIRST, THEY CHECKED THE MONITORING EQUIPMENT FOR DYSFUNCTION: EVERYTHING WAS STILL PROPERLY CONNECTED, AND ELECTRODES CHECK WERE ALL GOOD. SECONDLY, ENDOTRACHEAL TUBE MALPOSITION AND MISUSE OF PROLONGED MUSCULAR ANALGESICS: THEY OBTAINED A POSITIVE HIGH RESPONSE ON THE CONTRALATERAL LRN STIMULATION. FROM THE ANESTHESIA, THE TUBE WAS IN THE MEDIAN LINE AND WITH THE MARK ¿20¿ RIGHT ON THE LOWER TEETH. NO LOCAL ANALGESICS WERE USED, AND NO SIGNIFICANT SECRETIONS WERE PRESENT. AT THE SAME TIME THAT WE GOT A LOS ON THE LEFT SIDE THE RIGHT SIDE ALWAYS SHOWED A GREAT RESPONSE. THE DOCTORS TOLD ME THAT THIS IS THEIR THIRD TIME OCCURRING SOMETHING LIKE THIS AND WITHOUT ANY NERVE INJURY AFTERWORD. WE ALSO FILMED A VIDEO FROM THAT STIMULATION (VAGUS FROM THE LEFT SIDE WITH NO RESPONSE FROM NIM), THEY SAW THE CONTRACTION OF THE SURROUNDING MUSCLES. SURGERY WAS PERFORMED NORMALLY BUT WITHOUT ANY SIGNAL FROM THAT SIDE. THE SURGERY WAS EXTENDED FOR 20 MINUTES. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT(S). THERE WAS NO NERVE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391110 NIM® EMG STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. XOM UNK EMG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown