BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM 4.0 CONSOLE

    MDR report key: 21298230 · Received February 3, 2025

    Report

    Report Number
    1045254-2025-00252
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    December 15, 2024
    Report Date
    May 5, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    PMA / PMN Number
    K200759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION IN CONTINUATION OF D10: PRODUCT ID: NIM4CPB1, SERIAL: (B)(6), LOT: 225636516. H3 FOR THE CONCOMITANT PRODUCT (NIM4CPB1): PRODUCT ANALYSIS OF THE NIM 4.0 PATIENT INTERFACE (SERIAL: (B)(6)) FOUND THAT THE UNIT WAS PRESENTED WITH FULLY CHARGED BATTERIES. THERE WAS A WIRED CONNECTION FAILURE DUE TO A DEFECTIVE MAIN PCBA, AND A BROKEN BOTTOM CLIP. H6: PREVIOUSLY APPLIED CODE FDR C070601 IS NO LONGER APPLICABLE FOR CONCOMITANT PRODUCT. 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: INITIAL ANALYSIS FINDINGS FOR THE NIM CONSOLE FOUND THAT THERE WERE NO ERRORS REPRODUCED. THE WIRED CONNECTION RECOGNITION WAS SLOW. THE RIGHT SIDE OF THE DISPLAY WAS OFF. THE SOFTWARE VERSION PRESENT WAS V.1.6.4. CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NIM4CPB1, SERIAL: UNKNOWN, LOT: UNKNOWN. PRODUCT ID: NIM4CPB2, LOT: L12205043. H3 FOR CONCOMITANT PRODUCT: THE INITIAL ANALYSIS FINDINGS FOR THE PATIENT INTERFACE (NIM4CPB1) FOUND THAT THE CLIP WAS DAMAGED. THE SOFTWARE VERSION PRESENT WAS V.1.6.4. THE INITIAL ANALYSIS FINDINGS FOR THE PATIENT INTERFACE CONNECTING CABLE (NIM4CPB2) FOUND THAT IT WAS HARD TO CONNECT VIA WIRED CONNECTION. THE DIFFICULTY WITH WIRED CONNECTION WAS CAUSED BY THE CABLE. H6: FDR CODE C0201 IS APPLICABLE FOR THE NIM CONSOLE (NIM4CM01) AND FDR CODE C070601 IS APPLICABLE FOR NIM PATIENT INTERFACE (NIM4CPB1). ADDITIONAL CODES: IMG CODE G0201402 IS APPLICABLE FOR THE NIM CONSOLE (NIM4CM01) AND IMG CODE G0405204 IS APPLICABLE FOR NIM PATIENT INTERFACE (NIM4CPB1). 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: DURING THE INSPECTION OF THE NIM CONSOLE, IT WAS FOUND THAT UPON ACCEPTANCE, THE REQUESTED PHENOMENON COULD NOT BE OBSERVED, BUT IT WAS OBSERVED THAT THE GAP ON THE RIGHT SIDE OF THE DISPLAY WAS EXPANDING. H6: PREVIOUSLY APPLIED CODE FDR C0201 IS 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 DURING THYROIDECTOMY PROCEDURE, THERE WAS AN ERROR MESSAGE ¿OUT OF MEASUREMENT RANGE¿ AND ALONG WITH IT, AN ERROR WAS HEARD THAT SOUNDED LIKE WHEN STARTING UP A NIM. IT ALSO TAKES TIME TO READ THE INTERFACE WHEN THE INTERFACE CABLE IS CONNECTED. THE PROCEDURE WAS COMPLETED USING NIM3.0. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157610 NIM 4.0 CONSOLE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. NIM4CM01 226022870

    Patients

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