BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME

    MDR report key: 6698697 · Received July 10, 2017

    Report

    Report Number
    1045254-2017-00228
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Date of Event
    June 12, 2017
    Report Date
    June 12, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00613994499714
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 8253200 (PATIENT INTERFACE, RESPONSE 3.0): SERIAL NUMBER - (B)(4); LOT NUMBER ¿ 205997833; MANUFACTURED DATE ¿ JUNE 27, 2012; (B)(4); 510K - K083124. # 8253001 (MAINFRAME, NIM RESPONSE 3.0): THE DEVICE HAS BEEN RETURNED. THE PRODUCT ANALYSIS RESULTS ARE PENDING COMPLETION OF THE EVALUATION. # 8253200 (PATIENT INTERFACE, NIM RESPONSE 3.0): THE DEVICE CAME IN WITH WORN WAVE WASHERS, MISSING SPARE LABEL AND MISSING SPARE FUSES. THE PATIENT INTERFACE WAS DISASSEMBLED AND CLEANED. THE WAVE WASHERS REPLACED. FUSES AND LABEL WERE ADDED. THE PATIENT INTERFACE WAS REASSEMBLED AND TESTED TO MANUFACTURING SPECIFICATIONS WITH NO FAULT FOUND. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE 8253001 (MAINFRAME, NIM RESPONSE 3.0): THE PRODUCT ANALYSIS INDICATES THE DEVICE CAME IN WITH A FROZEN DISPLAY AND NO BEEPS AT STARTUP. THE DEVICE WAS DISASSEMBLED AND CLEANED. THE DEFECTIVE DSP (DISPLAY) PCBA WAS REPLACED. THE CF CARD WAS ALSO REPLACED TO UPGRADE THE SOFTWARE. THE DEVICE WAS REASSEMBLED AND PLACED INTO BURN-IN FOR 24 HOURS. THE DEVICE WAS TESTED TO MANUFACTURING SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A NURSE FROM THE FACILITY REPORTED THAT WHEN ATTEMPTING TO STIMULATE, THE NIM DID NOT HAVE ANY RESPONSE. THEY REDUCED THE THRESHOLD TO 80 AND THE STIM SETTING WAS 1.0. THE FUSES WERE REPLACED ON THE PATIENT INTERFACE BOX WITH NO RESOLUTION. THIS EVENT OCCURRED DURING THE END OF THE CASE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480358 NIM® 3.0 MAINFRAME STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 206001041 00613994499714

    Patients

    Seq Age Sex Outcome Treatment
    1