BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM-ECLIPSE® CONTROLLER

    MDR report key: 3902748 · Received June 30, 2014

    Report

    Report Number
    1030489-2014-02958
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    PMA / PMN Number
    K050798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ANALYSIS INDICATES THAT THE STIM BOARD (ASSY-2524-003) WAS REPLACED DUE TO THE STIM VOLTAGE TEST RESULTS FALLING BELOW SPECIFIED MINIMUM VALUES. THE ITEM WAS UPDATED TO CURRENT DESIGN SPECIFICATIONS. THE ITEM WAS TESTED AND PASSED MANUFACTURING SP ECIFICATIONS. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    THE NIM ECLIPSE CONTROLLER WAS RETURNED FOR PREVENTIVE MAINTENANCE. UPON EVALUATION OF THE DEVICE, IT WAS INDICATED THAT THE STIM VOLTAGE TEST RESULTS WERE BELOW MINIMUM SPECIFICATIONS AND NO ERROR MESSAGES WERE RECEIVED. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379551 NIM-ECLIPSE® CONTROLLER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. 945ECLC

    Patients

    Seq Age Sex Outcome Treatment
    1