BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

    MDR report key: 5160022 · Received October 19, 2015

    Report

    Report Number
    1045254-2015-00345
    Event Type
    Malfunction
    Date Received
    October 19, 2015
    Report Date
    September 21, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K112686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: MEDTRONIC RECEIVED MEDWATCH FORM 1045254-2015-00345-4 ON SEPTEMBER 21, 2015. IT WAS REPORTED THAT THERE WERE THREE CASES WITH THREE SEPARATE PATIENTS WHEREBY THE TRIVANTAGE EMG TUBE MAY NOT HAVE BEEN ¿PICKING UP THE RESPONSES/READING THE IMPULSES OF THE PATIENT WHILE THE TUBE WAS IN PLACE¿. IT WAS NOTED THAT IN ALL THREE CASES THE ANESTHESIOLOGIST AND/OR THE NEUROMONITORING TECHNICIAN WERE ABLE TO RESOLVE THE ISSUE WITH TROUBLESHOOTING. THIS REPORT IS BEING FILED TO ACKNOWLEDGE PATIENT THREE: 1045254-2015-00345-1 MALE; PARATHYROIDECTOMY PROCEDURE. MULTIPLE ATTEMPTS FOR INFORMATION FROM THE INITIAL REPORTER/USER FACILITY HAVE BEEN REQUESTED BUT NO NEW INFORMATION HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICES WERE DISCARDED BY USER FACILITY AND THE PRODUCT LOT/SERIAL NUMBERS WERE UNKNOWN BY THE REPORTER; THEREFORE, A PRODUCT EVALUATION COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CORRECTION: MEDTRONIC RECEIVED MEDWATCH FORM (B)(4) ON SEPTEMBER 21, 2015. IT WAS REPORTED THAT THERE WERE THREE CASES WITH THREE SEPARATE PATIENTS WHEREBY THE TRIVANTAGE EMG TUBE MAY NOT HAVE BEEN 'PICKING UP THE RESPONSES/READING THE IMPULSES OF THE PATIENT WHILE THE TUBE WAS IN PLACE'. IT WAS NOTED THAT IN ALL THREE CASES THE ANESTHESIOLOGIST AND/OR THE NEUROMONITORING TECHNICIAN WERE ABLE TO RESOLVE THE ISSUE WITH TROUBLESHOOTING. THIS REPORT IS BEING FILED TO ACKNOWLEDGE PATIENT THREE: (B)(6) MALE; PARATHYROIDECTOMY PROCEDURE. MULTIPLE ATTEMPTS FOR INFORMATION FROM THE INITIAL REPORTER/USER FACILITY HAVE BEEN REQUESTED BUT NO NEW INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    MEDWATCH FORM (B)(4) RECEIVED ON 09/21/2015. THE FOLLOWING WAS REPORTED: IT WAS REPORTED THAT THERE WERE THREE CASES WITH THREE SEPARATE PATIENTS WHEREBY THE TRIVANTAGE EMG TUBE MAY NOT HAVE BEEN "PICKING UP THE RESPONSES/READING THE IMPULSES OF THE PATIENT WHILE THE TUBE WAS IN PLACE." IT WAS NOTED THAT IN ALL THREE CASES NEITHER THE ANESTHESIOLOGIST NOR THE NEUROMONITORING TECHNICIAN WERE ABLE TO RESOLVE THE ISSUE WITH TROUBLESHOOTING. THIS REPORT IS BEING FILED TO ACKNOWLEDGE PATIENT THREE: (B)(6) MALE; PARATHYROIDECTOMY PROCEDURE. MULTIPLE ATTEMPTS FOR INFORMATION FROM THE INITIAL REPORTER/USER FACILITY HAVE BEEN REQUESTED BUT NO NEW INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689317 NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE® STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229708

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR