BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM

    MDR report key: 3890006 · Received April 23, 2014

    Report

    Report Number
    3890006
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    February 5, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    GWF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NIM (NERVE INTEGRITY MONITOR) 2.0 MUTING PROBE NOT WORKING AND HAS A NOISY ARTIFACT FROM THE BIPOLAR CAUTERY. WHENEVER THE CAUTERY IS APPLIED, THE NIM GIVES OFF A NOISY ARTIFACT. CURRENTLY UNAWARE IF ANY DELAYS DURING PROCEDURE; SURGEON ABORTED USE OF NIM MONITOR IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246691 NIM STIMULATOR, ELECTRICAL, NIM GWF MEDTRONIC NR-IP0529 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR ANY DELAYS DURING PROCEDURE, SURGEON ABORTED USE| OF NIM MONITOR IN THIS CASE.| GIVES OFF A NOISY ARTIFACT. CURRENTLY UNAWARE IF| WORKING AND HAS A NOISY ARTIFACT FROM THE BIPOLAR| NIM (NERVE INTEGRITY MONITOR) 2.0 MUTING PROBE NOT| CAUTERY. WHENEVER THE CAUTERY IS APPLIED, THE NIM