BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPUTER NOTEBOOK (INTERNATIONAL

    MDR report key: 25132010 · Received May 9, 2026

    Report

    Report Number
    3005677016-2026-00013
    Event Type
    Malfunction
    Date Received
    May 9, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 9, 2026
    Manufacturer
    MEDTRONIC (CHANGZHOU) MEDICAL DEVICES
    Product Code
    GWF
    UDI-DI
    00199150028207
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS PRODUCT IS NOT MARKETED IN US BUT SIMILAR DEVICE WITH PRODUCT NUMBER 945NCCPUE4 WITH 510(K)# K061639 IS MARKETED IN US. 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

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A COMPUTER NOTEBOOK USED FOR SPINAL THERAPY. IT WAS REPORTED THAT WHEN USING AUTOMATIC SEQUENCING IN THE EP SYSTEM, IT WAS POSSIBLE TO DIVIDE INTO FOUR GROUPS. HOWEVER, DIFFERENT SEQUENCE INTERVALS CANNOT BE SET FOR EACH OF THE FOUR GROUPS, AND ALL GROUPS WERE FORCED TO USE THE SAME INTERVAL (NUMBER OF SECONDS). THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621852 COMPUTER NOTEBOOK (INTERNATIONAL STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC (CHANGZHOU) MEDICAL DEVICES MCEQ2020 00199150028207

    Patients

    Seq Age Sex Outcome Treatment
    1