BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM TRIVANTAGE EMG TUBE, 7MM, 3/PK

    MDR report key: 3154907 · Received June 8, 2013

    Report

    Report Number
    1045254-2013-00413
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K112686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). PRODUCT DISCARDED BY FACILITY, NO EVALUATION AVAILABLE.

    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 THE TUBE DIDN'T GIVE ANY NERVE SIGNALS. NO INITIAL SIGNALS ON BOTH SIDES, LEFT AND RIGHT. NOT ON VAGUS <(>&<)> NOT ON NLR. ALSO, NOT AFTER DISSECTION. THERE WERE RARE ARTIFACTS WHILE MONOPOLAR CAUTERING, BUT VERY RARE. THEY ALSO RECEIVED SOME FEEDBACK WITH STRONG MANIPULATION OF THE TRACHEA. THEY DID THE COMPLETE SURGERY WITHOUT ANY SIGNAL OF THE NIM. PATIENT'S VOICE IS GOOD, SO NO PARESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256800 NIM TRIVANTAGE EMG TUBE, 7MM, 3/PK STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8229737 0206575365

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR