BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

    MDR report key: 4815958 · Received June 3, 2015

    Report

    Report Number
    1045254-2015-00189
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 12, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K112686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 8225101 - PROBE 8225101 5PK STD PRASS FLUSH TIP; MANUFACTURED DATE ¿ UNKNOWN; LOT ¿ UNKNOWN; 510K ¿ K934426. 8253001 - MAINFRAME 8253001 NIM RESPONSE 3.0; MANUFACTURED DATE ¿ MAY 23, 2015; SERIAL NUMBER - (B)(4); 510K ¿ K083124. (B)(6). (B)(4). THE EMG ET TUBE AND PROBE WERE DISCARDED BY THE CUSTOMER AND THEY WILL NOT BE RETURNING THE NIM 3.0 MAINFRAME FOR EVALUATION. THEREFORE, AN ANALYSIS HAS NOT BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING A THYROID CASE, THE NERVE LOCATION WAS KNOWN BUT THE SYSTEM WAS NOT DETECTING IT. THE DOCTOR VISUALLY SAW THE NERVES AND KNEW THERE WAS AN ISSUE AS THE SYSTEM WAS MAKING THE "WARBLE" SOUND VERSUS THE SOUND MADE WHEN DIRECTLY STIMULATING A NERVE. WHEN LOOKING AT THE TUBE AFTER THE CASE, THE DOCTOR AND SALES REP DISCUSSED THAT THE 22-24 CM DEPTH AT WHICH THE TUBE WAS INSERTED MAY HAVE HAD SOMETHING TO DO WITH THE FALSE NEGATIVE RESPONSE. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358983 NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE® STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229707

    Patients

    Seq Age Sex Outcome Treatment
    1