BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 INTERFACE

    MDR report key: 6943149 · Received October 11, 2017

    Report

    Report Number
    1045254-2017-00361
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Report Date
    September 15, 2017
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00613994858399
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICES: (B)(4)- NIM MAINFRAME RESPONSE 3.0, SERIAL # (B)(4), LOT # 66403800, MANUFACTURED DATE ¿ FEB/25/2010, 510(K) # K083124, UDI # (B)(4). THE NIM PATIENT INTERFACE (PRODUCT # 8253200RF) WAS RETURNED FOR ANALYSIS. EVALUATION COULD NOT DUPLICATE THE REPORTED EVENT OF NO STIMULATION RESPONSE. EVALUATION FOUND THAT THE DEVICE FAILED THE TRIBOELECTRIC IMMUNITY TEST AND THE P/I BOARD WAS LOOSE ON CHANNEL 2 PORT. THE CABLE WAS REPLACED. THE DEVICE WAS REPAIRED, TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. THE NIM MAINFRAME RESPONSE (PRODUCT # 8253001) WAS RETURNED FOR ANALYSIS. EVALUATION COULD NOT DUPLICATE REPORTED EVENT OF NO STIMULATION RESPONSE. EVALUATION FOUND THAT THE FEET WERE MISSING ON THE DEVICE, THE FEET WERE REPLACED. THE SOFTWARE WAS UPGRADED TO CURRENT SPECIFICATIONS. THE DEVICE WAS TESTED WITH THE P/I CABLE AND IT PASSED ALL MANUFACTURING SPECIFICATIONS. THERE WAS NO FUNCTIONAL FAULT FOUND WITH THE DEVICE. THE DEVICE WAS TESTED TO MANUFACTURER PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THERE WAS NO STIMULATION RESPONSE FROM THE NIM SYSTEM. BIOMEDICAL ENGINEER AT THE FACILITY COULD NOT DUPLICATE THE ISSUE OF NO STIMULATION RESPONSE THAT WAS FOUND DURING SURGERY. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720873 NIM® 3.0 INTERFACE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. 8253200RF 69916500 00613994858399

    Patients

    Seq Age Sex Outcome Treatment
    1