BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

    MDR report key: 5140434 · Received October 9, 2015

    Report

    Report Number
    1045254-2015-00328
    Event Type
    Injury
    Date Received
    October 9, 2015
    Date of Event
    September 17, 2015
    Report Date
    September 17, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K112686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. CONDITION UPON RECEIPT: 1 UN-SEALED SAMPLE, PART NUMBER 8229708, FROM LOT NUMBER 0207797907 RECEIVED; THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE]. EQUIPMENT USED: MICROSCOPE (ZEISS STEMI 2000C BETWEEN 0, 65 TO 5, 0 MAGNIFICATION SETTINGS), CALIPERS. EVALUATION: A SYRINGE WAS USED TO INFLATE THE CUFF WITH AIR AND IT LEAKED OUT IN UNDER 10 SECONDS, CONFIRMING THE REPORTED EVENT. WHEN VIEWED UNDER MAGNIFICATION, THERE WAS A CUT IN THE CUFF MEASURING 0.02¿ IN THE APPROXIMATE CENTER OF THE CUFF AND ALIGNED WITH THE MURPHY EYE. THERE WAS NO DAMAGE TO THE PACKAGING THAT WOULD INDICATE A CAUSE FOR THE CUT. BASED ON THE AVAILABLE INFORMATION AND THE PRODUCT ANALYSIS THE CUT LIKELY OCCURRED DURING OPERATIONAL CONTEXT OF THE DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE THE EMG TUBE CUFF WAS LEAKING. THE TUBE WAS REMOVED AND A NEW TUBE WAS PLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT IMPACT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671626 NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE® STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229708 0207797907

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention