BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM-NEURO® 3.0 MAINFRAME

    MDR report key: 6535198 · Received May 1, 2017

    Report

    Report Number
    1045254-2017-00138
    Event Type
    Injury
    Date Received
    May 1, 2017
    Date of Event
    April 6, 2017
    Report Date
    April 6, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: 8228052: ELECTRODE 8228052 APS 2MM, LOT 0212228369 MANUFACTURED 2016-10-31 USE BEFORE 2020-10-10 UDI:(B)(4). USAGE OF DEVICE: INITIAL USE 510(K) - K083124 H3: PRODUCT EVALUATION: ANALYSIS RESULTS NOT AVAILABLE; DEVICES NOT RETURNED FOR EVALUATION. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT HAS BEEN CONFIRMED THAT THE PATIENT IS BEING FOLLOWED UP WITH "ORTHOPHONIA PROTOCOL". SHE IS CURRENTLY "DOING WELL".

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT DURING A THYROIDECTOMY, THE RECURRENT NERVE WAS CUT. IT WAS CONFIRMED THAT THIS WAS A PATIENT INJURY WITHOUT MALFUNCTION OF THE NIM SYSTEM; ALL COMPONENTS OF THE NIM SYSTEM WERE WORKING AS EXPECTED. THE SURGEON WAS ABLE TO REPAIR BY SUTURING THE NERVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315777 NIM-NEURO® 3.0 MAINFRAME STIMULATOR, NERVE GWF MEDTRONIC XOMED INC. 8253402

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention