BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM TRIVANTAGE EMG TUBE, 7MM

    MDR report key: 3072933 · Received April 23, 2013

    Report

    Report Number
    1045254-2013-00345
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 29, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K112686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). METHOD - PRODUCT WAS DISCARDED BY FACILITY, WILL NOT BE RETURNED FOR EVALUATION.

    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 THE FACILITY STATED THERE WAS A HOLE IN THE CUFF. THIS WAS DISCOVERED DURING THE PROCEDURE AND THEY HAD TO RE-INTUBATE THE PATIENT. THEY WERE ABLE TO COMPLETE THE SURGERY AND THE PATIENT WAS REPORTED TO BE FINE. THE TUBE WAS DISCARDED BY THE FACILITY AND WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173274 NIM TRIVANTAGE EMG TUBE, 7MM STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8229707 0206745547

    Patients

    Seq Age Sex Outcome Treatment
    1