BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMG REINFORCED ENDOTRACHEAL TUBE

    MDR report key: 1920103 · Received December 3, 2010

    Report

    Report Number
    1045254-2010-00061
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER REGARDING BOTH PRODUCT AND PATIENT INFORMATION. ANY MISSING OR INCOMPLETE DATA FROM FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED, OR RELEASED BY THE REPORTER DESPITE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION. THE ATTEMPTS TO ACQUIRE ADDITIONAL INFORMATION ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT IS USED FOR TREATMENT AND NOT FOR DIAGNOSES.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED TO THE COMPANY SALES MANAGER THAT, DURING A PREVIOUS PROCEDURE, HE PERFORMED, A PATIENT WAS INTUBATED WITH A MEDTRONIC XOMED EMG ENDOTRACHEAL TUBE AND SOME SORT OF EVENT OCCURRED. THE SALES MANAGER HAD TO PROVIDE WHICH MEDTRONIC EMG TUBE WAS BEING USED AT THAT TIME. THE (B)(6) OF THE ANESTHESIA DEPARTMENT WAS CONTACTED FOR ADDITIONAL INFORMATION. HE STATED HE WAS MADE AWARE OF THE INCIDENT ONLY THROUGH "E-MAIL CHAINS." THE ANESTHESIOLOGIST STATED THAT AFTER THE SCHEDULED SURGICAL PROCEDURE, A STYLET WAS PASSED DOWN THE EMG TUBE. THE END OF THE STYLET HAD A "HOCKEY STICK SHAPE TO IT" AND WAS ALLOWED TO EXTEND PAST THE DISTAL TIP OF THE EMG TUBE. THE PATIENT'S TRACHEA WAS SOMEHOW LACERATED AND A FLAP OF TISSUE CAUSED BLOCKING THE AIRWAY REQUIRING AN EMERGENCY TRACHEOTOMY. THE BELIEVES THE STYLET HAD CAUSED THE LACERATION, AND DID NOT BELIEVE THE EMG TUBE HAD CAUSED ANY DAMAGE DUE TO THE SOFT SILICONE DISTAL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMG REINFORCED ENDOTRACHEAL TUBE ETN - STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention