BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

    MDR report key: 22978519 · Received September 5, 2025

    Report

    Report Number
    9612501-2025-02343
    Event Type
    Injury
    Date Received
    September 5, 2025
    Date of Event
    August 4, 2025
    Report Date
    October 4, 2025
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    ETN
    UDI-DI
    00763000033958
    PMA / PMN Number
    K112686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    H3: PRODUCT ANALYSIS FOUND THAT, THE DEVICE, PACKAGING TRAY, 2 RED/WHITE ELECTRODES, 1 GREEN ELECTRODE, AND AN OPEN POUCH WERE RETURNED IN A LARGE PLASTIC SLEEVE. THE POUCH WAS OPEN FROM 3 OF 4 SIDES WHEN RETURNED. THERE WERE TRACES OF CONTAMINATION OBSERVED ON THE CUFF. IT WAS ALSO OBSERVED THAT UPON RETURN, THE ADAPTER FROM THE PROXIMAL END OF THE DEVICE WAS MISSING. HOWEVER, THERE WERE NO TRACES OF KINKED, INDENT, OR STICKY TAPE MARKS OBSERVED ON THE RETURNED DEVICE. H6: THE PREVIOUSLY APPLIED CODES FDM B21, FDR C21 AND FDC D16 ARE NO LONGER APPLICABLE.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 DURING THE THYROID SURGERY, THERE WAS A KINK OF THE INTUBATION TUBE DURING THE OPERATION WHICH AFFECTED THE VENTILATION. THEY HAVE MANUALLY RESHAPED THE KINK SECTION OF THE INTUBATION TUBE WITHOUT EXTUBATING TO ENSURE SMOOTH VENTILATION. THERE WAS A DELAY OF 20 MINUTES IN THE SURGERY. THE PATIENT IS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305605 NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE® STIMULATOR, NERVE ETN MEDTRONIC DOMINICANA 8229707 0228487917 00763000033958

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other