BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM 4.0 CONSOLE

    MDR report key: 22960351 · Received September 4, 2025

    Report

    Report Number
    1045254-2025-02089
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 8, 2025
    Report Date
    October 28, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00763000395896
    PMA / PMN Number
    K200759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS FOUND VERIFIED NOT WORKING PROPERLY. UNIT PRESENTED WITH 1.7.5 SOFTWARE AND DEFECTIVE SSD PCBA BOARD 1.1.1. H6: CODES APPLICABLE ARE FDM B01, FDR C0201, FDC D16 AND IMG G02005. CONCOMITANT MEDICAL PRODUCTS: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: 1. PRODUCT ID: (B)(4) , SERIAL/LOT #: (B)(6) , UDI#: (B)(4) ; H3: PRODUCT ANALYSIS FOUND UNIT PRESENTED WITH SOFTWARE 1.7.5. NO FAULT FOUND. H6: CODES APPLICABLE ARE FDM B01, FDR C19, FDC D14 AND IMG G02005. 2. PRODUCT ID: (B)(4) , SERIAL/LOT #: (B)(6) , UDI#: (B)(4) H3: PRODUCT ANALYSIS FOUND UNIT PRESENTED WITH SOFTWARE 1.7.5. AND BROKEN CLIPS AND BOTTOM HOUSING/CASE. H6: CODES APPLICABLE ARE FDM B01, FDR C070603, FDC D16 AND IMG G0405204, G04070. 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

    H6: PREVIOUSLY APPLIED CODE FDC D16 IS NO LONGER APPLICABLE. FDC D02 IS 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); H6: PREVIOUSLY APPLIED CODE FDC D16 IS NO LONGER APPLICABLE. FDC D20 IS APPLICABLE. 2. PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6), UDI#: (B)(4), H6: PREVIOUSLY APPLIED CODE FDC D16 IS NO LONGER APPLICABLE. FDC D20, D1102 ARE 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNIT WAS NOT OPERATIONAL. THERE WAS NO KNOWN PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233631 NIM 4.0 CONSOLE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. NIM4CM01 00763000395896

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown