BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME INTERNATIONAL

    MDR report key: 20331021 · Received September 30, 2024

    Report

    Report Number
    1045254-2024-01639
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 3, 2024
    Report Date
    January 21, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00643169230392
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8253200, SERIAL/LOT #: (B)(6) , UDI#: (B)(4), PRODUCT ANALYSIS: MAINFRAME (B)(6). PRODUCT ANALYSIS STATED FOUND FUSE OF THE PATIENT INTERFACE STIM 1 BLOW. CHANGING FUSE OF STIM 1 SYSTEM WORKED NORMALLY. AND NO FAULT FOUND IN MAINFRAME IMDRF CODES: IMG G02030, FDD A090803, FDR C19, FDC D20 & FDM B01 PRODUCT ANALYSIS: PATIENT INTERFACE (B)(6) PRODUCT ANALYSIS STATED FOUND FUSE OF THE PATIENT INTERFACE STIM 1 BLOW. CHANGING FUSE OF STIM 1 SYSTEM WORKED NORMALLY IMDRF CODES: FDD A090803, IMG G0201202, FDR C0201, FDC D02 & 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

    ADDITIONAL INFORMATION RECEIVED STATING THE ISSUE OCCURRED PRIOR TO THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN NIM MAINFRAME THERE WAS NO STIMULATION RESPONSE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2595118 NIM® 3.0 MAINFRAME INTERNATIONAL STIMULATOR, NERVE GWF MEDTRONIC XOMED INC. 8253002 210668075 00643169230392

    Patients

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