BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM

    MDR report key: 12275496 · Received August 4, 2021

    Report

    Report Number
    1045254-2021-00428
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    December 17, 2015
    Report Date
    August 4, 2021
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: XOM UNK NIMINTRFC, SERIAL/LOT #: NO INFORMATION, PRODUCT ID: XOM UNK EMG FLEX, SERIAL/LOT #: NO INFORMATION, PRODUCT ID: XOM UNK NIMELECTRO, SERIAL/LOT #: NO INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    KATRIN BRAUCKHOFF, RENATE VIK, LORENTZ SANDVIK2, JOHN-HELGE HEIMDAL, TURID AAS, MARTIN BIERMANN, MICHAEL BRAUCKHOFF "IMPACT OF EMG CHANGES IN CONTINUOUS VAGAL NERVE MONITORING IN HIGH-RISK ENDOCRINE NECK SURGERY" IN WORLD J SURG (2016) 40:672680 DOI 10.1007/S00268-015-3368-Y REPORTED EVENT (S) THE STUDY IS PART OF A LARGER ONGOING PROSPECTIVE STUDY ON IONM AND VOICE CHANGES DURING THYROID AND PARATHYROID SURGERY. THE PRESENT ANALYSIS INCLUDES 55 PATIENTS. THE ARTICLE REPORTS THAT ONE PATIENT MALE, (B)(6) YEARS OLD SUSTAINED AN ACUTE THERMAL INSULT ON THE RIGHT SIDE, RESULTING IN PERMANENT PALSY (> 6 MONTHS), AND ONE PATIENT MALE, (B)(6) YEARS OLD WHO THEY HAD TO USE INTERMITTENT NERVE STIMULATION AFTER THE CONTINUOUS INTRAOPERATIVE NERVE MONITORING MALFUNCTIONED, SUSTAINED A LEFT SIDED INJURY RESULTING IN TRANSIENT PALSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173537 NIM STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. XOM UNKNOWN NIM

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other