BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM 4.0 CONSOLE

    MDR report key: 23376654 · Received October 24, 2025

    Report

    Report Number
    1045254-2025-02420
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    September 30, 2025
    Report Date
    January 30, 2026
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00763000528577
    PMA / PMN Number
    K200759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    H3: PRODUCT ANALYSIS FOUND THE NIM VITAL CONSOLE HAS BEEN RECEIVED IN GOOD CONDITION, NO DEVIATIONS HAVE BEEN FOUND. H6: PREVIOUSLY APPLIED CODES FDM B17, FDR C20, FDC D16 ARE NO LONGER APPLICABLE. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: 1. PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6), UDI#: (B)(4). H3: PRODUCT ANALYSIS FOUND THE NIM VITAL PATIENT MODULE HAS BEEN RECEIVED IN GOOD CONDITION, NO DEVIATIONS HAVE BEEN FOUND. THE OUTER SHROUD IS COMING OFF. H6: CODES APPLICABLE ARE FDM B01, FDR C070603, FDC D1102 AND IMG G04070. 2. PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6), UDI#: (B)(4). H3: PRODUCT ANALYSIS FOUND THE NIM VITAL PATIENT MODULE HAS BEEN RECEIVED IN GOOD CONDITION, NO DEVIATIONS HAVE BEEN FOUND. H6: CODES APPLICABLE ARE FDM B01, FDR C19, FDC D14, D1102 AND IMG G02005. 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 WHILE IN USE, IT FAILED TO DETECT OR STIMULATE. USER CHECKED THROUGH THE SETTINGS AND THE ONLY WARNING THE MACHINE STATES IS THAT IT IS OVERDUE A SERVICE. THE NERVE COULD NOT BE VISUALIZED AS THERE WAS A LOT OF BLOOD IN THE FIELD. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446018 NIM 4.0 CONSOLE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. NIM4CM01 00763000528577

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown