BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM CONTACT®

    MDR report key: 3854197 · Received June 6, 2014

    Report

    Report Number
    1045254-2014-00129
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TUBE LUMEN WAS CLOSELY OBSERVED AND NO BLOCKAGE WAS OBSERVED. THERE WERE NO SIGNS OF DELAMINATION OF INNER COIL AND THERE WERE NO INDICATIONS OF DEVICE KINKING THAT WOULD INDICATE DEVICE BLOCKAGE. THE ELECTRODE WIRES (BLUE AND RED) WERE FOUND CUT, LIKELY BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    EXPORT ONLY. NOT MARKETED OR SOLD IN THE US. THE DEVICE HAS NOT BEEN RETURNED. AN EVALUATION/ANALYSIS OF THE DEVICES CANNOT BE PERFORMED AT THIS TIME. METHOD: ACTUAL DEVICE NOT EVALUATED. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING SURGERY ON (B)(6) 2014, THE INNER LUMEN OF THE ENDOTRACHEAL TUBE WAS HERNIATED, DECREASING THE PATIENT'S OXYGEN LEVEL. THE ANESTHESIOLOGIST REPLACED THE EMG FLEX TUBE WITH NO PROBLEMS TO THE PATIENT. THE SURGERY ENDED WITH NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331545 NIM CONTACT® STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229980 0207682445

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR