BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM-NEURO® 3.0 MAINFRAME

    MDR report key: 4806320 · Received May 29, 2015

    Report

    Report Number
    1045254-2015-00186
    Event Type
    Injury
    Date Received
    May 29, 2015
    Date of Event
    April 29, 2015
    Report Date
    May 6, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: MUTING PROBE 8220325 NIM, 510K: K083124. LOT NUMBER UNKNOWN.(B)(4). THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS.

    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 THYROIDECTOMY CASE THE NIM WAS ¿GOING BERSKERK¿ AND THE DOCTOR CUT A NERVE. A WEEK AFTER THIS CASE THE DOCTOR REQUESTED THE SALES REP TO TURN THE THRESHOLD DOWN ON THE DEVICE. IT WAS NOTED DURING THE SITE VISIT THAT THE MUTE DETECTOR WAS CLEARLY BROKEN, WITH A LARGE HUNK OF METAL SHEARED OFF. THE SALES REP LATER CLARIFIED THE REPORTED INFORMATION ¿GOING BERSHERK.¿ SALES REP EXPLAINED: ¿IF MUTING DETECTOR ISN'T WORKING CORRECTLY THE MONITOR TRIES TO SELF-REGULATE THE THRESHOLD. IT SPEAKS TO YOU AS IT CHANGES SETTINGS- SAYS ¿THRESHOLD INCREASE¿ OR ¿DECREASE¿. DR SAID IT WAS DOING THIS NONSTOP (WHICH WOULD CORRELATE WITH A BROKEN MUTING DETECTOR). SO HE ASSUMED SOMETHING WAS WRONG WITH THE MACHINE AND TURNED IT OFF.¿ IT IS NOT KNOWN AT THIS TIME WHAT MEDICAL INTERVENTION WAS PERFORMED, OR WHAT IS THE CURRENT STATUS OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350397 NIM-NEURO® 3.0 MAINFRAME STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253401 209046369

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention