BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM TRIVANTAGE® EMG ENDOTRACHEAL TUBE

    MDR report key: 3884276 · Received June 19, 2014

    Report

    Report Number
    1045254-2014-00136
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K112686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE PRODUCT WAS DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. METHOD: NO TESTING METHODS PERFORMED.

    Description of Event or Problem · 1

    TOWARDS THE END OF A RIGHT THYROID PROCEDURE, WHEN THE ANESTHESIOLOGIST WENT TO DO A VALSALVA, THE SURGEON STATED THE TUBE WAS LEAKING. THE ANESTHESIOLOGIST CHECKED THE CUFF AND STATED THEY DID NOT PUT ENOUGH AIR IN THE CUFF. THERE WAS NO PATIENT IMPACT. THE TUBE WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS. DURING FOLLOW-UP CONVERSATIONS POST-SURGERY, THE SURGEON INSISTED THAT THE TRI-VANTAGE TUBE HAD A LEAK. A SECOND CASE WAS PERFORMED THE SAME DAY WHICH USED A TRI-VANTAGE TUBE AND WAS COMPLETED WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360036 NIM TRIVANTAGE® EMG ENDOTRACHEAL TUBE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229707 0208333369

    Patients

    Seq Age Sex Outcome Treatment
    1