BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME INTERNATIONAL

    MDR report key: 6708696 · Received July 12, 2017

    Report

    Report Number
    1045254-2017-00237
    Event Type
    Malfunction
    Date Received
    July 12, 2017
    Date of Event
    June 16, 2017
    Report Date
    June 16, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00613994529053
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: 8253200 (PATIENT INTERFACE, RESPONSE 3.0): SERIAL NUMBER - (B)(4); LOT NUMBER ¿ 70047700; MANUFACTURED DATE ¿ OCTOBER 13, 2010; UDI ¿ (B)(4); 510K - K083124. THE 8253002 (MAINFRAME, NIM RESPONSE 3.0): THE PRODUCT ANALYSIS INDICATES THE REPORTED ISSUE COULD NOT BE REPRODUCED OR CONFIRMED. A 48-HOUR BURN-IN WAS PERFORMED WITH NO DEVIATIONS FOUND. THERE WAS NO FAULT FOUND. THE DEVICE WAS SUCCESSFULLY TESTED TO SPECIFICATIONS. 8253200 (PATIENT INTERFACE, NIM RESPONSE 3.0): THE DEVICE HAS NOT BEEN RETURNED. A PRODUCT ANALYSIS HAS NOT BEEN PERFORMED. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NIM 3.0 MAINFRAME WAS NOT RESPONDING TO STIMULUS. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487759 NIM® 3.0 MAINFRAME INTERNATIONAL STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253002 66515000 00613994529053

    Patients

    Seq Age Sex Outcome Treatment
    1