BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM-NEURO® PATIENT INTERFACE

    MDR report key: 23669355 · Received November 28, 2025

    Report

    Report Number
    1045254-2025-02647
    Event Type
    Malfunction
    Date Received
    November 28, 2025
    Date of Event
    July 31, 2025
    Report Date
    January 19, 2026
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00643169782464
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: FDC D02 CODE IS NO LONGER APPLICABLE. H6: SERIAL NUMBER: (B)(6): FDC D1102 CODE IS APPLICABLE. H6: SERIAL NUMBER: (B)(6): FDC D16 CODE NO LONGER APPLICABLE. H6: SERIAL NUMBER: (B)(6): FDC D02 CODE IS APPLICABLE. H6: SERIAL NUMBER: (B)(6): FDC D16 CODE NO LONGER APPLICABLE. H6: SERIAL NUMBER: (B)(6): FDC D02 CODE IS APPLICABLE. H6: SERIAL NUMBER: (B)(6): FDC D16 CODE NO LONGER APPLICABLE.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.

    Additional Manufacturer Narrative · 0

    H3: IT WAS FOUND IN THE ANALYSIS THAT THE WAVE WASHER WAS WORN. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8253401, PRODUCT DESCRIPTION: MAINFRAME 8253401 NIM NEURO 3.0; SERIAL/LOT #: (B)(6), UDI#: (B)(4) H3: SERIAL NUMBER: (B)(6): IT WAS FOUND IN THE ANALYSIS THAT THE INTERFACE PCB WAS DEFECTIVE. H6: SERIAL NUMBER: (B)(6): FDM B01, FDR C0201, IMG G02005, AND FDC D02 CODES ARE APPLICABLE. PRODUCT ID: 8253200, PRODUCT DESCRIPTION: PATIENT INTERFACE 8253200 RESPONSE 3.0, SERIAL/LOT #: (B)(6), UDI#: (B)(4); H6: SERIAL NUMBER: (B)(6): FDM B17, FDR C20, IMG G02005, AND FDC D16 CODES ARE APPLICABLE. PRODUCT ID: 8253001, PRODUCT DESCRIPTION: MAINFRAME 8253401 NIM NEURO 3.0, SERIAL/LOT #: (B)(6), UDI#: (B)(4) H6: SERIAL NUMBER: (B)(6): FDM B17, FDR C20, IMG G02030, AND FDC D16 CODES 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. 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 DURING PRE-OP, THE PATIENT INTERFACE AND MAINFRAME CHANNEL WAS NOT WORKING. IT DID NOT DISPLAY NERVE STIMULATION IN A CRANIOTOMY. THEY BROUGHT IN A SECOND SYSTEM; IT DID NOT WORK EITHER. DURING TROUBLESHOOTING THE CASE ENDED AND TESTED THE DEVICE WITH THE PATIENT SIMULATOR AND BOTH UNITS SEEMED TO OPERATE CORRECTLY. THE PROCEDURE WAS COMPLETED WITHOUT NERVE MONITORING. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2399921 NIM-NEURO® PATIENT INTERFACE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253410 00643169782464

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11...."