BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 INTERFACE

    MDR report key: 22517991 · Received July 16, 2025

    Report

    Report Number
    1045254-2025-01789
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    June 18, 2025
    Report Date
    August 1, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00643169782440
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: 8253002, SERIAL/LOT #:(B)(6), UBD: , UDI#: (B)(4). ADDITIONAL CODE OF IMG G02030 IS APPLICABLE FOR PRODUCT ID: 8253002, SERIAL/LOT #: (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

    H3: DEVICE ANALYSIS DID NOT CONFIRM THE REPORTED ISSUE; THE DEVICE WAS TESTED WITH THE CUSTOMER-OWNED NIM MAINFRAME AND ALL SIGNALS WORKED AS EXPECTED. CROSS-TESTING WITH TEST EQUIPMENT ALSO SHOWED NO DEVIATIONS IN THE SIGNALS. HOWEVER, THE CLAMPS WERE FOUND TO BE BENT AND LOOSE DUE TO WORN WAVE WASHERS. H6: PREVIOUSLY APPLIED CODES OF FDM B17, FDR C20 AND FDC D16 ARE NO LONGER APPLICABLE. H3: DEVICE ANALYSIS FOR PRODUCT ID: 8253002, SERIAL/LOT #: (B)(6). DID NOT CONFIRM THE REPORTED ISSUE; THE DEVICE WAS TESTED WITH THE CUSTOMER-OWNED NIM MAINFRAME AND ALL SIGNALS WORKED AS EXPECTED. CROSS-TESTING WITH TEST EQUIPMENT ALSO SHOWED NO DEVIATIONS IN THE SIGNALS AND THERE WAS NO FAULT FOUND. H6: CODE OF FDR C19 IS APPLICABLE FOR PRODUCT ID: 8253002, SERIAL/LOT #: (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

    H6: ADDITIONAL CODES OF IMG G0405203 AND IMG G04138 WERE NOT SUBMITTED IN PREVIOUS REGULATORY REPORT. 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 THE NIM 3.0 SYSTEM PASSED THE TEST BUT DID NOT FUNCTION CORRECTLY ON THE PATIENT. THE TESTS FAILED TO TURN GREEN WHEN ACTUAL CONSUMABLES WERE CONNECTED TO THE PATIENT, DESPITE TRYING MULTIPLE SETS OF CONSUMABLES. THERE WAS NO IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555083 NIM® 3.0 INTERFACE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. 8253200 00643169782440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown