BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 2.0 MAINFRAME

    MDR report key: 5656206 · Received May 16, 2016

    Report

    Report Number
    1045254-2016-00147
    Event Type
    Malfunction
    Date Received
    May 16, 2016
    Report Date
    April 19, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    IKN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICE: 8252800: INTERFACE 8252800 RESPONSE 2.0 INCREMENT, S/N (B)(4), LOT 56523600, MANUFACTURED: 06/16/2008. PRODUCT EVALUATION: ANALYSIS RESULTS NOT AVAILABLE; NO DEVICES RETURNED FOR EVALUATION.

    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 THE "OLD SYSTEM IS UNRELIABLE AND INCREASINGLY NOT USER-FRIENDLY. SOMETIMES THEY ARE VISIBLY LOOKING AT THE NERVE AND SEEING IT AND NOT SEEING IN ON THE MONITOR WITH STIMULATION." THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312217 NIM® 2.0 MAINFRAME ELECTROMYOGRAPH, DIAGNOSTIC IKN MEDTRONIC XOMED INC. 8252001IP 56541200

    Patients

    Seq Age Sex Outcome Treatment
    1