BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM-NEURO® 3.0 MAINFRAME

    MDR report key: 7336055 · Received March 13, 2018

    Report

    Report Number
    1045254-2018-00109
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    February 14, 2018
    Report Date
    March 13, 2018
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00613994529077
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 8253410 (PATIENT INTERFACE 8253410 NIM NEURO 3.0): SERIAL NUMBER - (B)(4); LOT NUMBER ¿ 206315473; MANUFACTURED DATE ¿ NOVEMBER 2, 2012; UDI # - (B)(4); 510K - K083124. THE 8253402 (MAINFRAME) - THE PRODUCT ANALYSIS INDICATES THAT SERVICE AND REPAIR WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THERE WAS NO FAULT FOUND WITH THE MAINFRAME; IT WAS TESTED AND PASSED, MEETING MANUFACTURING SPECIFICATIONS. 8253410 (PATIENT INTERFACE) - THE PRODUCT ANALYSIS CONFIRMED THE REPORTED MALFUNCTION. STIM1 WAS NOT WORKING DUE TO A BLOWN FUSE. THE FUSE AND WAVE WASHERS WERE REPLACED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE MEDTRONIC FINLAND FACILITY REPORTED THAT THE NIM MAINFRAME AND PATIENT INTERFACE WERE NOT RESPONSIVE. THERE WAS NO MENTION OF PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178403 NIM-NEURO® 3.0 MAINFRAME STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253402 205854226 00613994529077

    Patients

    Seq Age Sex Outcome Treatment
    1