BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME

    MDR report key: 7364975 · Received March 23, 2018

    Report

    Report Number
    1045254-2018-00122
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    February 28, 2018
    Report Date
    March 23, 2018
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00613994499714
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8253200, SERIAL/LOT #: (B)(4), MANUFACTURED DATE: OCTOBER 3, 2013, UDI #: (B)(4), 510K: K083124; 8253001 (MAINFRAME, NIM 3.0): THE PRODUCT ANALYSIS INDICATES THERE WAS NO FAULT FOUND WITH THE MAINFRAME. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE MAINFRAME WAS TESTED AND PASSED TO MANUFACTURING SPECIFICATIONS. THE 8253200 (PATIENT INTERFACE, NIM 3.0): THE PRODUCT ANALYSIS INDICATES THE REPORTED ISSUE COULD NOT BE DUPLICATED. A BROKEN CABLE CLIP AND WORN WAVE WASHER WERE REPLACED. THE PATIENT INTERFACE WAS TESTED WITH THE CUSTOMER'S MAINFRAME AND PASSED ALL MANUFACTURING SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INTEROPERATIVELY, THE NIM 3.0 RESPONSE WAS STIMULATING INTERMITTENTLY WHEN IT SHOULD NOT HAVE BEEN. THERE WAS NO PATIENT IMPACT. THIS REGULATORY REPORT REPRESENTS CASE 2 OF 2. CASE 1 OF 2, INTERNAL REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208504 NIM® 3.0 MAINFRAME STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 207555673 00613994499714

    Patients

    Seq Age Sex Outcome Treatment
    1