BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME INTERNATIONAL

    MDR report key: 4743359 · Received May 1, 2015

    Report

    Report Number
    1045254-2015-00139
    Event Type
    Malfunction
    Date Received
    May 1, 2015
    Date of Event
    March 24, 2015
    Report Date
    April 6, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS 8253200: PATIENT INTERFACE 8253200 RESPONSE 3.0, S/N (B)(4), LOT 72641400, MANUFACTURED: 03/31/2011; 8220300: PROBE 8220300 NIM MUTING DETECTOR, LOT UNKNOWN, MANUFACTURED: UNKNOWN. PRODUCT EVALUATION: -- EVALUATION OF THE MAINFRAME (8253002) IN SERVICE AND REPAIR FOUND NO FAULT WITH THE DEVICE. SOFTWARE WAS UPGRADED TO CURRENT SPECIFICATIONS AND THE DEVICE WAS TESTED, AND PASSED, TO MANUFACTURING SPECIFICATIONS. -- EVALUATION OF THE INTERFACE (8253200) IN SERVICE AND REPAIR FOUND NO FAULT WITH THE DEVICE. UNIT TESTED TO MANUFACTURING SPECIFICATIONS; ALL TESTS PASSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM "CANNOT DETECT NERVE WHILE IN CASE". "MACHINE OK" WHILE BEING USED WITH SIMULATOR. TO PROCEED WITH THE CASE THEY CHANGED TO "ANOTHER MACHINE" SO THAT THE "NERVE COULD BE DETECTED." THE SYSTEM WAS "FAULTY FOR ABOUT 6 CASES." THERE WAS NO PATIENT IMPACT. THIS MEDWATCH IS BEING FILED FOR ONE OF THE SIX CASES. THE FIVE OTHER CASES WILL BE REPORTED UNDER THE FOLLOWING MEDTRONIC INTERNAL REFERENCE NUMBER (THE REGULATORY REPORT NUMBER WAS NOT AVAILABLE AT THE TIME OF SUBMISSION): (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288698 NIM® 3.0 MAINFRAME INTERNATIONAL STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253002 64205700

    Patients

    Seq Age Sex Outcome Treatment
    1