BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM 4.0 CONSOLE

    MDR report key: 21533506 · Received March 6, 2025

    Report

    Report Number
    1045254-2025-00729
    Event Type
    Malfunction
    Date Received
    March 6, 2025
    Date of Event
    February 5, 2025
    Report Date
    March 6, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00763000528577
    PMA / PMN Number
    K200759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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), UDI#: (B)(4). PRODUCT ID: NIM4CPB1, SERIAL/LOT #: (B)(6), UDI#: (B)(4). PRODUCT ANALYSIS: CONSOLE ((B)(6)). PRODUCT ANALYSIS STATED NO ABNORMALITIES WERE FOUND IN DEVICE. IMDRF CODES: IMG G02030, FDD A090803, FDR C19, FDC D1102 < (>&<)> FDM B01 PRODUCT ANALYSIS: PATIENT INTERFACE ((B)(6)). PRODUCT ANALYSIS STATED NO ABNORMALITIES WERE FOUND IN DEVICE. IMDRF CODES: IMG G02005, FDD A090803, FDR C19, FDC D1102 < (>&<)> FDM B01 PRODUCT ANALYSIS: PATIENT INTERFACE ((B)(6)). PRODUCT ANALYSIS STATED NO ABNORMALITIES WERE FOUND IN DEVICE. IMDRF CODES: IMG G02005, FDD A090803, FDR C19, FDC D1102 < (>&<)> FDM B01. 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 PROCEDURE IN NIM DEVICE AT TIMES IT WAS OVERSTIMULATING AND IN OTHER CASES UNDER STIMULATING. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592427 NIM 4.0 CONSOLE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. NIM4CM01 227314162 00763000528577

    Patients

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