BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMG TUBE 8229737 3PK NIM TRIVANTAGE 7MM

    MDR report key: 4245783 · Received November 12, 2014

    Report

    Report Number
    1045254-2014-00291
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K112686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.(B)(4). PRODUCT EVALUATION: NO ANALYSIS RESULTS AVAILABLE; DEVICE DISCARDED BY USER FACILITY AND NOT RETURNED. METHOD: NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    BRAND NAME: EMG TUBE 8229737 3PK NIM TRIVANTAGE 7MM. MODEL #: 8229737. DATE MFR REC: NOVEMBER 12, 2014. PMA/510(K): K112686.

    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 DURING A TOTAL THYROIDECTOMY, THE EMG TUBE GOT ¿FLOPPY AND SOFT¿ AND THE ANESTHESIOLOGIST COULD NOT INTUBATE THE PATIENT. THE SURGERY HAD TO BE CANCELLED. THE EVENT WAS CLARIFIED AS FOLLOWS: ¿ANESTHESIA COULD NOT INTUBATE WITH THE NIM CONTACT TUBE USING A GLIDE SCOPE, DESPITE 3 ATTEMPTS. THEY CAUSED SIGNIFICANT AIRWAY EDEMA. PATIENT HAD A MASSIVE SUB-STERNAL GOITER, AND, GIVEN THE AIRWAY EDEMA, THE CASE WAS CANCELLED TO BE RESCHEDULED AT A LATER DATE.¿ IT WAS CONFIRMED THAT ¿THE CASE WAS RESCHEDULED AT PENN MEDICINE, HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA. THE OPERATION WAS COMPLETED WITHOUT INCIDENT, WITHOUT USE OF THE NIM TUBE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729330 EMG TUBE 8229737 3PK NIM TRIVANTAGE 7MM STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8229737

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention