BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACH TUBE 8229507 CONTACT EMG 7MM

    MDR report key: 3557788 · Received January 7, 2014

    Report

    Report Number
    1045254-2014-00007
    Event Type
    Injury
    Date Received
    January 7, 2014
    Date of Event
    September 19, 2013
    Report Date
    December 16, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICES: 8253001 MAINFRAME, 8253001 NIM RESPONSE 3.0 K083124, 8253200 PATIENT INTERFACE, 8253200 RESPONSE 3.0 K083124, 8253600 PATIENT SIMULATOR, 8253600 NIM 3.0 UNIV K083124, 8220325 MUTING PROBE, 8220325 NIM K083124, 8253030 KEYBOARD, 8253030 MEDICAL GRADE, 8225101 PRASS MONOPOLAR STIMULATING PROBE K934426. (B)(4). A SLIGHT OR INCOMPLETE PARALYSIS. (B)(4). PRODUCT EVALUATION: NO ANALYSIS AVAILABLE. EMG TUBE WAS DISCARDED BY FACILITY, CONCOMITANT DEVICES WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT WAS OPERATED ON FOR A TOTAL THYROIDECTOMY USING THE SIZE 7 EMG CONTACT ENDOTRACHEAL TUBE. TUBE WAS PLACED AND THE NERVE MONITOR HOOKED UP AND FOUND TO BE FUNCTIONING. DURING THE CASE THE SURGEON IDENTIFIED THE NERVES BUT THE STIMULATOR WAS NOT STIMULATING THE NERVE. THEY CHECKED THE CONNECTIONS AND THEY APPEARED TO BE IN ORDER. THEY DID NOT CHECK TUBE PLACEMENT IN THE LARYNX AS THE PATIENT WAS DRAPED. SURGERY CONTINUED AS IF THE SURGEON WAS DOING A CASE WITHOUT THE NERVE MONITOR. ONCE SURGERY WAS COMPLETED, THE SURGEON WAS CALLED TO SEE THE PATIENT IN RECOVERY AS SHE HAD NOISY BREATHING. THE PATIENTS' OXYGEN SATURATIONS WERE NORMAL BUT THERE WAS A MILD INSPIRATORY STRIDOR. THE SURGEON PERFORMED A FIBEROPTIC LARYNGOSCOPY AND NOTED SIGNIFICANT EDEMA IN THE LARYNX. BOTH THE ARYTENOIDS WERE VERY SWOLLEN AND THE VOCAL CORDS WERE NOT MOVING. THE VOCAL CORDS WERE IN PARAMEDIAN POSITION AND THE AIRWAY WAS OPEN. PATIENT WAS ALSO HAVING TROUBLE SWALLOWING. THE SURGEON STARTED THE PATIENT ON SOME ANTI-INFLAMMATORIES AND GOT A MONITORED BED FOR AIRWAY OBSERVATION AND POTENTIAL TRACHEOSTOMY. AFTER TWO DOSES OF ANTI-INFLAMMATORIES, THE PATIENT WAS ABLE TO SWALLOW AND THE STRIDOR DISAPPEARED. VOCAL CORD MOBILITY WAS STILL NOT BACK. THE PATIENT IS REGAINING MOBILITY OF THE VOCAL CORDS WITH TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10613 ENDOTRACH TUBE 8229507 CONTACT EMG 7MM STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8229507

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention