BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM TRIVANTAGE® EMG ENDOTRACHEAL TUBE

    MDR report key: 3913776 · Received July 3, 2014

    Report

    Report Number
    1045254-2014-00143
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K112686
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (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 PATIENT¿S SOFT PALLET GOT TORN IN A THYROID CASE WHERE A TRIVANTAGE EMG TUBE WAS USED. FURTHER FOLLOW UP WITH THE SURGEON LEARNED THAT HE HAD NO ISSUES WITH THE TUBE BUT INDICATED IT WAS MOST LIKELY THE ANESTHESIOLOGIST¿S ISSUE WITH PLACING THE TUBE; HE INDICATED THE ANESTHESIOLOGIST HAD CALLED THE TUBE A ¿WEAPON¿ AND PREFERS THE SILICONE TUBES. THE PROCEDURE WAS A TOTAL THYROIDECTOMY. THE LACERATION OCCURRED UPON INSERTION OF THE TUBE. THERE WAS A SLIGHT DELAY TO TREAT THE INJURY AND REINTUBATE THE PATIENT. THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND WAS REPORTED TO BE IN GOOD CONDITION POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389616 NIM TRIVANTAGE® EMG ENDOTRACHEAL TUBE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229707 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention