BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMARK SYSTEM

    MDR report key: 24115633 · Received January 20, 2026

    Report

    Report Number
    3016813690-2026-00001
    Event Type
    Injury
    Date Received
    January 20, 2026
    Date of Event
    January 5, 2026
    Report Date
    January 20, 2026
    Manufacturer
    NEURENT MEDICAL LTD.
    Product Code
    GEI
    PMA / PMN Number
    K250048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLEEDING IS A KNOWN POTENTIAL ADVERSE EVENT AND IS DOCUMENTED IN THE DEVICE LABELLING.

    Description of Event or Problem · 0

    PATIENT EXPERIENCED A LEFT-SIDED POSTERIOR BLEED 4 WEEKS POST NEUROMARK PROCEDURE. PATIENT REQUIRED EMBOLIZATION OF BILATERAL SPA AND LEFT FACIAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178242 NEUROMARK SYSTEM RADIOFREQUENCY PROBE GEI NEURENT MEDICAL LTD. NMK00301

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention| H