BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENT NIM P/N UNKNOWN

    MDR report key: 3213415 · Received July 9, 2013

    Report

    Report Number
    1045254-2013-00446
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. IT HAS NOT BEEN CONFIRMED THE IONM DEVICE MENTIONED IN THIS ARTICLE AS A MEDTRONIC DEVICE. THE ARTICLE ALSO MENTIONED A "NIM EMG ENDOTRACHEAL TUBE; MEDTRONIC, MINNEAPOLIS MN, USA" WAS USED IN THE PROCEDURE. NO PART NUMBER, LOT NUMBER OR SERIAL NUMBER WAS PROVIDED, THEREFORE THE MANUFACTURE AND EXPIRATION DATES ARE NOT AVAILABLE. (B)(4). PRODUCT WAS NOT RETURNED FOR EVALUATION. NO TESTING METHODS PERFORMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE, WORLD JOURNAL OF SURGICAL ONCOLOGY 2013, 11:94; PROTECTIVE EFFECT OF INTRAOPERATIVE NERVE MONITORING AGAINST RECURRENT LARYNGEAL NERVE INJURY DURING RE-EXPLORATION OF THE THYROID. ONE OF THE 70 RLNS (RECURRENT LARYNGEAL NERVE) RE-EXPLORED WITH IONM (INTRAOPERATIVE NERVE MONITORING), WAS ACCIDENTLY INJURED. IT WAS STATED THE IONM DEVICE MALFUNCTIONED ONCE DURING AN OPERATION, WHICH RESULTED IN THE ACCIDENTAL RLN TRANSECTION. THEY WERE UNAWARE OF THE RLN INJURY UNTIL THEY USED THE IONM TO CHECK THE VAGUS NERVE AND RECEIVED NO RESPONSE. IN CONTRAST, THE CONTRALATERAL VAGUS NERVE RESPONDED WELL TO STIMULATION. THEY IDENTIFIED THE TRANSECTED END OF THE RLN USING A NERVE STIMULATOR AND DID A RE-ANASTOMOSIS WITH THE ANSA-CERVICALIS NERVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313018 ENT NIM P/N UNKNOWN ETN MEDTRONIC XOMED, INC. XOM UNKNOWN NIM NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention