BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM 4.0 CONSOLE

    MDR report key: 22476783 · Received July 11, 2025

    Report

    Report Number
    1045254-2025-01715
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    June 17, 2025
    Report Date
    August 7, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00763000395896
    PMA / PMN Number
    K200759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT NUMBER: NIM4CBP1, DESCRIPTION: PATIENT INTERFACE NIM4CPB1 NIM 4.0, SERIAL NUMBER: UNKNOWN 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 CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT NUMBER: NIM4CBP1, DESCRIPTION: PATIENT INTERFACE NIM4CPB1 NIM 4.0, SERIAL NUMBER: (B)(6); PRODUCT NUMBER: NIM4CBP1, DESCRIPTION: PATIENT INTERFACE NIM4CPB1 NIM 4.0, SERIAL NUMBER: (B)(6), H6: PREVIOUSLY SUBMITTED CODE FDC D16 IS NO LONGER APPLICABLE. FDC CODES D1102 IS APPLICABLE FOR NIM4CM01 AND D20 IS APPLICABLE FOR NIM4CBP1 SERIAL NUMBER: (B)(6). OTHER CONCOMITANT DEVICES INVOLVED IN THE EVENT WHICH REASONABLY SUGGEST THAT THESE DEVICE MAY NOT HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY ARE PRODUCT NUMBER: 8220325, DESCRIPTION: MUTING PROBE 8220325 NIM; PRODUCT NUMBER: NIM4CPB2, DESCRIPTION: CONN CABLE NIM4CPB2 PAT INTFC NIM 4.0. 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, THE STAFF COULD NOT GET THE PATIENT INTERFACE(PI) BOX CONNECTED TO THE VITAL UNIT. TRIED CONNECTING ANOTHER PI BOX. SWITCHED OUT THE SYSTEM AND USED THE NIM 3.0. SALES REPRESENTATIVE (REP.) WAS NOTIFIED BY A STAFF MEMBER THAT THE SYSTEM WAS NOT WORKING, THE SURGERY WAS ALREADY COMPLETED WHEN REP. REACHED THE FACILITY. REP. TESTED THE SYSTEM AND DID NOT FIND ANYTHING WRONG WITH CONNECTION. THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED TRIED BOTH MODES WIRED AND WIRELESS. SALES REPRESENTATIVE (REP.) TESTED THE SYSTEM AND DID NOT FIND ANYTHING WRONG WITH CONNECTION. BOTH THE MUTING PROBE WAS BROKEN AND THE INTERFACE CONNECTER WAS NOT WORKING. THERE WAS CUT IN THE INTERFACE CABLE. ORDERED NEW CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873478 NIM 4.0 CONSOLE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. NIM4CM01 00763000395896

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male