BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM CONTACT® STANDARD EMG REINFORCED ENDOTRACHEAL TUBE

    MDR report key: 4226418 · Received November 5, 2014

    Report

    Report Number
    1045254-2014-00284
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4).CONCOMITANT PRODUCTS: MAINFRAME 8253002 NIM RESPONSE 3.0 INTL ; 510K:K083124 ; SERIAL # (B)(4); MANUFACTURED DATE: JULY 12, 2012. THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. METHOD: NO TESTING METHODS PERFORMED.

    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 PATIENT WAS ANESTHETIZED FOR THYROIDECTOMY IN THE ANESTHESIA ROOM, WHERE THE DEVICE WORKED PROPERLY, SHOWING GREEN TICK MARKS AS INDICATORS THAT IT WAS SAFE TO PROCEED WITH USE OF THE EQUIPMENT. ONCE IN THE OPERATING ROOM, THE SYSTEM BEGAN TO INTERMITTENTLY LOSE SIGNAL, AND THESE GREEN TICK MARKS WOULD DISAPPEAR, THEN REAPPEAR. THE MEDICAL TEAM CHANGED THE EMG TUBE OUT, BELIEVING THAT THIS MIGHT SOLVE THE PROBLEM (TOTAL QUANTITY OF 2 USED). WHEN THE INTERMITTENT BEHAVIOR CONTINUED, THE CASE WAS CANCELLED. THERE WAS NO PATIENT INJURY. THE SITE HAS SINCE DETERMINED THAT THE SIGNAL PROBLEM MOST LIKELY OCCURRED DUE TO HOSPITAL CONSTRUCTION GOING ON NEARBY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710836 NIM CONTACT® STANDARD EMG REINFORCED ENDOTRACHEAL TUBE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229307 0208352423

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization