BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME INTERNATIONAL

    MDR report key: 21716234 · Received March 28, 2025

    Report

    Report Number
    1045254-2025-00984
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    March 3, 2025
    Report Date
    May 2, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: THE CUSTOMER COMPLAINT CAN BE CONFIRMED. THE DEVICE CAN RANDOMLY STUCK BEFORE BOOT ON UEFI SHELL SCREEN WITH ERROR OF MISSING MAP. THE SOFTWARE IS UP TO DATE. VER: 3.1.0.5; GUI V2015.10.9.918; DSP V2015.8.28.1058 IS PRESENT. THE DSP BOARD IS DAMA GED. PREVIOUS CODES B17, C20, D16 AND G02005 ARE NO LONGER APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRE-OP, THE DEVICE FREEZES UP AT START, NEEDS MULTIPLE REBOOTS. DEVICE DOESN'T WORK AFTER MULTIPLE REBOOTS. THERE WAS NO PATIENT IMPACT IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603458 NIM® 3.0 MAINFRAME INTERNATIONAL STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253002 218144448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown