BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE

    MDR report key: 2883240 · Received December 21, 2012

    Report

    Report Number
    1045254-2012-00753
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    July 11, 2012
    Report Date
    November 21, 2012
    Manufacturer
    MEDTRONIC INC.
    Product Code
    ETN
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP RECEIVED ON (B)(6) 2013 CONFIRMED THAT THE PATIENT WAS FINE. ADDITIONALLY, THE ACCOUNT COULD NOT CONFIRM THAT THE PREVIOUSLY REPORTED LOT NUMBER 0205736322 WAS THE LOT INVOLVED IN THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    OCCLUSION; (B)(4): VENTILATION ISSUE IN DEVICE ENVIRONMENT (B)(4): THE DEVICE WAS NOT RETURNED. THE DEVICE WAS NOT RETURNED AND THEREFORE NO EVALUATION COULD BE PERFORMED. METHOD: NO TESTING METHODS PERFORMED (B)(4). RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (B)(4). CONCLUSION: DEVICE NOT RETURNED (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED MEDWATCH FDA FORM # (B)(4) ON (B)(6) 2012, DETAILING THE EVENT BELOW: ON (B)(6) 2012, A (B)(6) MALE PATIENT WAS UNDERGOING A THYROIDECTOMY WITH NECK DISSECTION. GENERAL ANESTHESIA USED, NO DIFFICULTY WITH INTUBATION USING CUFFED 7.0 MM ET TUBE. DURING THE SURGICAL PROCEDURE, THE PATIENT BECAME HYPOXIC AND UNABLE TO VENTILATE. PER ANESTHESIA NOTES, PLACEMENT OF ENDOTRACHEAL TUBE CHECKED WITH GLIDE SCOPE SHOWING GOOD PLACEMENT, BUT PATIENT CONTINUED TO DESATURATE AND UNABLE TO VENTILATE. EMERGENT TRACHEOSTOMY PERFORMED, SURGICAL PROCEDURE ABORTED. CHEST X-RAY COMPLETED SHOWING EXTENSIVE INFILTRATES IN RIGHT LUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE 8229307 NIM EMG 7MM RE STIMULATOR, NERVE ETN MEDTRONIC INC. 8229307 0205736322

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR Hospitalization