BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NERVEANA NEUROVISION SE

    MDR report key: 6812608 · Received August 23, 2017

    Report

    Report Number
    6812608
    Event Type
    Malfunction
    Date Received
    August 23, 2017
    Date of Event
    July 6, 2017
    Report Date
    August 16, 2017
    Manufacturer
    NEUROVISION MEDICAL PRODUCTS, INC.
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A TOTAL THYROIDECTOMY AND CENTRAL COMPARTMENT NECK DISSECTION WITH NERVE REPAIR THE NERVANA MACHINE DIDN'T ALERT WHEN STIMULATING THE NERVE, CONNECTIONS CHECK AND IN PLACE - ET TUBE CHANGED AND REPOSITIONED BY THE ANESTHESIOLOGIST. AT THE BEGINNING OF THE CASE, THE NERVANA TUBE WAS PLACED UNEVENTFULLY, APPEARED TO RESPOND NORMALLY, MORE THAN HALFWAY THRU THE CASE A SMALL LEAK WAS NOTED IN THE ETT BALLOON, RE-INFLATED 3-4 TIMES BY LIFTITNG DRAPE, AFFIRMING POSITION, AND RETAPING. DURING THE CASE, THE PATIENT DID REQUIRE REINTUBATION, SAME TUBE REPLACED, RE-TAPED. SMALL LEAK STILL NOTED, NO TROUBLE VENTILATING AND OXYGEN SATS 90'S - 100% THE SURGEON DID NOTE "NERVE INJURY" REPAIRED SURGICALLY AT THE TIME. THE NERVANA TUBE WAS NO LONGER WORKING, A SMALL HOLE WAS NOTED IN THE EET NEAR DISTAL END, THE MACHINE WAS TAKEN TO BIOMED INSPECTED THE UNIT DID NOT DETERMINE MALFUNCTION OF THE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593839 NERVEANA NEUROVISION SE STIMULATOR, NERVE ETN NEUROVISION MEDICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other