BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM-NEURO® 3.0 MAINFRAME

    MDR report key: 7261356 · Received February 9, 2018

    Report

    Report Number
    1045254-2018-00050
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Date of Event
    January 17, 2018
    Report Date
    March 26, 2018
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00613994529077
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: 8253410 - PATIENT INTERFACE NIM NEURO 3.0, SERIAL # (B)(4), LOT # 207821036, MANUFACTURED DATE ¿ JANUARY 9, 2014, 510(K) # K083124, (B)(4). NO EVALUATION PERFORMED; PRODUCTS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE THERE WAS NO SIGNAL FROM THE NIM NEURO MAINFRAME WHEN IMPULSE WAS GIVEN TO THE NERVE. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE USER MAYBE USING A NON-MEDTRONIC TUBES WITH THE NIM 3.0 WHICH COULD BE THE REASON WHY THE NIM STOPPED WORKING. THE DEVICE IS WORKING FINE AND THERE ARE NO PROBLEMS.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED NO SOUND OR IMPULSE WAS HEARD DURING THE PROCEDURE. THE DEVICE HAS BEEN IN THE CUSTOMER'S POSSESSION FOR A WHILE AND RECENTLY SWITCHED ON A TUBE WITH THE ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102265 NIM-NEURO® 3.0 MAINFRAME STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253402 207863043 00613994529077

    Patients

    Seq Age Sex Outcome Treatment
    1