BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® 3.0 MAINFRAME INTERNATIONAL

    MDR report key: 21457977 · Received February 25, 2025

    Report

    Report Number
    1045254-2025-00595
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    November 15, 2022
    Report Date
    February 25, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    GWF
    UDI-DI
    00613994529053
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF THE DEVICE FOUND THAT THE REPORTED ISSUE WAS NOT CONFIRMED. HOWEVER THE DEVICE DOES NOT KEEP IT'S TIME AND DATE SETTINGS, INDICATING AN EMPTY MAINBOARD BATTERY. 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). H6: CODES OF FDR C0601, FDR C07, FDR C070601 AND FDC D02 ARE APPLICABLE FOR PRODUCT ID: 8253200, SERIAL/LOT #: (B)(6). ADDITIONAL CODES OF IMG G04070, IMG G0201202, IMG G02004, IMG G04058 AND IMG G0405203 ARE APPLICABLE FOR PRODUCT ID: 8253200, SERIAL/LOT #: (B)(6). H4: MANUFACTURING DATE FOR PRODUCT ID: 8253200, SERIAL/LOT #: (B)(6) WAS 16 JANUARY 2018. THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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 PRE-OP, THE MAINFRAME DOES NOT GIVE STIMULUS, HAD DAMAGED REAR CONNECTION AND PATIENT INTERFACE DOES NOT WORK. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094579 NIM® 3.0 MAINFRAME INTERNATIONAL STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED INC. 8253002 00613994529053

    Patients

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