BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8253401 NIM NEURO 3.0

    MDR report key: 3201145 · Received July 2, 2013

    Report

    Report Number
    1045254-2013-00439
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 7, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCT: 8253410, PATIENT INTERFACE 8253410 NIM NEURO 3.0, S/N (B)(4), LOT 206343205. MANUFACTURED 11-13-2012. (B)(4). DEVICE OPERATES DIFFERENTLY THAN EXPECTED. EVALUATION SUMMARY: UPON EVALUATION THE CONDITION OF THE DEVICES SHOWED NO SIGNIFICANT PHYSICAL DAMAGES. THE CUSTOMER¿S MAINFRAME WAS POWERED ON WITH THE CUSTOMER¿S INTERFACE; SERVICE AND REPAIR¿S SIMULATOR, AND SERVICE AND REPAIR¿S PROBE WERE CONNECTED. IT WAS NOTED THAT THE TOUCHSCREEN BUTTONS WERE SLOW TO RESPOND DURING THE EVALUATION, INDICATING THAT THE TOUCHSCREEN MAY REQUIRE ROUTINE CALIBRATION. THE DETAILED ELECTRODE CHECK SCREEN WAS ACCESSED. ALL THE MONITORING CHANNEL READINGS WERE RED DUE TO READING HIGH IMPEDANCES, TYPICALLY AROUND 10KOHMS. THE ELECTRODE CHECK DID NOT CONSISTENTLY IDENTIFY THE PRESENCE OF EITHER STIM OR THE GROUND CONNECTIONS. THE STRAIN RELIEFS OF THE INTERFACE WERE FLEXED; THE STIM/GROUND IMPEDANCE READINGS WOULD APPEAR AND DISAPPEAR INTERMITTENTLY, AND CHANNEL READINGS CONTINUED TO TYPICALLY BE HIGH (HIGHEST READING SEEN WAS ABOUT 13KOHMS; RARELY, SOME CHANNELS DID READ AS ¿GREEN¿). THE CUSTOMER¿S INTERFACE WAS DISCONNECTED FROM THE MAINFRAME AND REPLACED WITH SERVICE AND REPAIR¿S INTERFACE AND SERVICE AND REPAIR¿S SIMULATOR AND PROBE WERE CONNECTED TO THAT INTERFACE. THE ELECTRODE CHECK READINGS ALL BECAME ¿GREEN.¿ DURING ANALYSIS, NO OUT OF SPECIFICATION CONDITIONS WERE FOUND WITH THE MAINFRAME, (B)(4); HOWEVER, AN OUT OF SPECIFICATION CONDITION RELATED TO THE REPORTED EVENT WAS FOUND WITH THE INTERFACE, (B)(4). THE CABLE WAS REPLACED. THE UNIT WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE ON ALL CHANNELS AND THE GROUND DROPPED OUT WHEN CHECKING ON SIMULATOR; THERE WAS NO REPORTED PATIENT IMPACT. IT WAS CONFIRMED THAT THE USER FEELS THIS IS AN INTERMITTENT ISSUE, AND THEY RECEIVED NO WARNING OR ERROR MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301611 MAINFRAME 8253401 NIM NEURO 3.0 STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8253401 206281931

    Patients

    Seq Age Sex Outcome Treatment
    1