BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMG REINFORCED ENDOTRACHEAL TUBE

    MDR report key: 241316 · Received September 17, 1999

    Report

    Report Number
    1045254-1999-00008
    Event Type
    Death
    Date Received
    September 17, 1999
    Date of Event
    May 3, 1999
    Report Date
    August 23, 1999
    Manufacturer
    XOMED SURGICAL PRODUCTS, INC.
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LEARNED OF EVENT UPON IN-SERVICE REQUEST AT HOSP. PT UNDERWENT SURGERY FOR PARTIAL TUMOR REMOVAL ON 4/26/1999, AND AGAIN ON 5/3/1999 FOR REMOVAL OF REMAINING PORTION. A XOMED EMG TUBE WAS USED FOR BOTH CASES. THE SURGERY PROGNOSIS WAS UNK, BUT PT WAS STABLE WHEN TRANSFERRED TO ICU. WHEN MOVED, THE ATTENDING ANESTHESIA PROVIDER DID NOT EXTUBATE THE EMG TUBE. INSTEAD, THE MONITORING LEADS WERE REMOVED FROM THE EMG TUBE AND PT WAS SENT TO ICU WITH TUBE IN PLACE. IN ICU, THE PT EXPERIENCED MULTIPLE SEIZURES. RECEIVED INJECTIONS FOR RELAXATION DURING A PERIOD OF 12 HOURS. WHILE THE PT WAS IN A NON-RESPONSIEVE STATE. THE ICU NURSING PERSONNEL HAD DIFFICULTY CLEARING THE EMG TUBE. PT EXPIRED IN THE ICU AROUND MIDNIGHT ON MAY 4TH. THE XOMED TUBE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMG REINFORCED ENDOTRACHEAL TUBE ENDOTRACHEAL TUBE BTR XOMED SURGICAL PRODUCTS, INC. NA 17978500

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death