BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM 4.0 CONSOLE

    MDR report key: 22950959 · Received September 3, 2025

    Report

    Report Number
    1045254-2025-02087
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    August 8, 2025
    Report Date
    September 29, 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

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6), UBD: , UDI#: (B)(4) H3: ANALYSIS RESULTS FOR PRODUCT ID: NIM4CPB1 WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. H4: MANUFACTURING DATE FOR PRODUCT ID: NIM4CPB1 IS 2023-04-11 H6: FDD CODE A051203, FDM B21, FDR C21 AND IMG G02005 ARE APPLICABLE FOR PRODUCT ID: NIM4CPB1, SERIAL #: (B)(6) 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

    B5: UPDATED H3: PRODUCT ANALYSIS VERIFIED 'NON-SPECIFIC/DAMAGED.' UNIT PRESENTED WITH SW:(V1.7.5), FULLY CHARGED BATTERIES, A MISSING OUTER SHROUD, A CRACKED ENCLOSURE WITH LOOSE FUSE O-RINGS, AND AN ELECTRODE FAILURE DUE TO BROKEN AFE PCBA ELECTRODE PINS. H6: PREVIOUSLY SUBMITTED CODES FDM B21, FDR C21 AND FDC D16 ARE NO LONGER APPLICABLE. CODES FDM B01, FDR C0201, C07 AND C0706 IS APPLICABLE FOR PRODUCT NUMBER: NIM4CPB01, SERIAL NUMBER: (B)(6). 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 PREOPERATIVELY, NIM CONSOLE KEPT GIVING ERROR MESSAGE TO RESTART. PATIENT INTERFACE UNIT WAS DROPPED AND WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH OTHER PI BOX. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    THE CONSOLE WAS REBOOTED AND KEYBOARD CAME UP MULTIPLE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2450480 NIM 4.0 CONSOLE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. NIM4CM01 00763000395896

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11