BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM-NEURO® 3.0 MAINFRAME

    MDR report key: 6926437 · Received October 7, 2017

    Report

    Report Number
    1045254-2017-00350
    Event Type
    Malfunction
    Date Received
    October 7, 2017
    Report Date
    September 12, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00643169230378
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT PERFORMED; PRODUCT WAS NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE DEVICE WAS NOT WORKING. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705686 NIM-NEURO® 3.0 MAINFRAME STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. 8253402 210586164 00643169230378

    Patients

    Seq Age Sex Outcome Treatment
    1