BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® 3.0 MAINFRAME

    MDR report key: 6267618 · Received January 20, 2017

    Report

    Report Number
    1045254-2017-00038
    Event Type
    Injury
    Date Received
    January 20, 2017
    Report Date
    December 22, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00613994499714
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT DATE OF THIS EVENT IS UNKNOWN; HOWEVER, THE MONTH AND YEAR HAVE BEEN CONFIRMED AS (B)(6) 2017. CONCOMITANT DEVICES: UNKNOWN PATIENT INTERFACE -- UNKNOWN NIM EMG TUBE. PRODUCT EVALUATION: THE DEVICE (MAINFRAME, 8253001) WAS RECEIVED IN SERVICE AND REPAIR FOR EVALUATION. ANALYSIS FOUND NO FAULT WITH THE UNIT. THE DEVICE WAS SUCCESSFULLY TESTED TO ALL MANUFACTURING SPECIFICATIONS.

    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 THYROID PROCEDURE, THE NIM SYSTEM ¿NEVER WENT OFF¿; THE PATIENT¿S NERVE WAS CUT. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51181 NIM® 3.0 MAINFRAME STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 208166796 00613994499714

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability