BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8252001 NIM-RESPONSE 2.0

    MDR report key: 2853410 · Received November 30, 2012

    Report

    Report Number
    1045254-2012-00692
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Report Date
    November 1, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE NIM SYSTEM (MAINFRAME, INTERFACE, STIMULATOR, MUTING PROBE) WERE RETURNED TO THE MANUFACTURER. THE SERVICE AND REPAIR TECHNICIAN CONFIRMED THE COMPLAINT (WARNINGS FAILURE/VOLUME NOT LOUD ENOUGH). THE EVALUATION IDENTIFIED A MAINFRAME CPU BOARD AND AUDIO MIXER BOARD FAILURE; BOTH ITEMS WERE REPLACED. THE INTERFACE, STIMULATOR, MUTING PROBE RECEIVED PREVENTATIVE MAINTENANCE. THE SYSTEM WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. THE SYSTEM AND ITS ACCESSORY COMPONENTS WERE RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NIM MAINFRAME VOLUME WAS NOT LOUD ENOUGH AND THE WARNINGS WERE NOT WORKING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, IMPACT, OR INJURY. THE SYSTEM WAS SENT TO THE MANUFACTURER'S SERVICE AND REPAIR FOR EVALUATION AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAINFRAME 8252001 NIM-RESPONSE 2.0 STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8252001 36778600

    Patients

    Seq Age Sex Outcome Treatment
    1