BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM 4.0 CONSOLE

    MDR report key: 22520850 · Received July 16, 2025

    Report

    Report Number
    1045254-2025-01799
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    February 1, 2024
    Report Date
    September 15, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00763000395896
    PMA / PMN Number
    K200759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS OBSERVED NO ANOMALIES HAVE BEEN FOUND. SECTION H6: CODES B01, C19 AND IMG G02030 ARE APPLICABLE FOR NIM CONSOLE. 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), UDI#: (B)(4) SECTION H6: CODES B21, C21 AND IMGG02005 ARE APPLICABLE FOR PATIENT INTERFACE. 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: THE FDC D20 AND D14 CODE WERE UPDATED. FDC D16 CODE WERE NO LONGER APPLICABLE FOR NIM CONSOLE. H3: PRODUCT ANALYSIS CONFIRMED THE REPORTED ISSUE AND FOUND THAT LEADS SOCKETS ARE LOOSE, AFE BOARD WAS DAMAGED AND BATTERY WAS MORE THAN TWO YEARS OLD. H6: CODES C070601, C070601, C07, D02 , G02002 AND G02025 WERE UPDATED FOR PATIENT INTERFACE. THE PREVIOUSLY UPDATED CODES B21 AND C21 ARE APPLICABLE FOR PATIENT INTERFACE. 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 INTRA OPERATIVE THE NIM CONSOLE HAD HIGH AMOUNT OF ARTIFACTS. EVEN WHEN THE SOUND IS MUTED TO 5 PERCENT'S WHICH IS A SAFE MINIMUM, THE ARTIFACTS ARE VERY DISTURBING, THE DEVICE SHOWS ARTIFACTS CONSTANTLY AND VERY INTENSELY WHILE THE SURGEON IS ONLY STANDING NEXT TO THE PATIENT. THE DEVICE USUALLY CUTS OUT FOR A WHILE WITH SUCH HIGH ARTIFACTS AND AFTER A WHILE THE ARTIFACTS START AGAIN. FURTHERMORE, THE DEVICE VERY OFTEN DOES NOT DETECT A COMPLETELY EXPOSED NERVE. THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION STATED THAT THE NIM CONSOLE EXPERIENCED PERSISTENT ARTIFACTS THAT DISRUPTED MONITORING AND NERVE RESPONSE DET ECTION, DESPITE TROUBLESHOOTING EFFORTS. THE ISSUE, PRESENT SINCE THE DEVICE'S PURCHASE, HAS NOT BEEN RESOLVED EVEN AFTER MULTIPLE REPAIR ATTEMPTS. ALTHOUGH NORMAL MONITORING WAS CONTINUED WITH THE SOUND TURNED OFF EXCEPT DURING STIMULATION, THE ARTIFACTS IMPACTED NERVE RESPONSE DETECTION. ELECTROSURGICAL EQUIPMENT (BIPOLAR WITH ULTRASOUND AND MONOPOLAR) WAS USED, BUT NOT DURING STIMULATION, AND PROPER PRECAUTIONS TO AVOID EMG LEADS INTERFERENCE WERE FOLLOWED. THE CONSOLE SHOWED A TONE EVEN THOUGH THE SURGEON WAS STANDING NEXT TO THE PATIENT AND DIDN'T TOUCH THE PATIENT, DIDN'T APPLY PHYSICAL PRESSURE, DIDN'T STIMULATE, DIDN'T USE ELECTROSURGICAL EQUIPMENT. THE MUTE DETECTOR FAILED TO RECOGNIZE ELECTROCAUTERY SIGNALS, AND NO ERROR MESSAGES WERE DISPLAYED. THE PROBLEM WAS NOT RESOLVED THROUGH REPOSITIONING OR TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540016 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...."