BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXONICS

    MDR report key: 23295296 · Received October 15, 2025

    Report

    Report Number
    2124215-2025-72249
    Event Type
    Death
    Date Received
    October 15, 2025
    Date of Event
    September 1, 2025
    Report Date
    October 14, 2025
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340455
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET/510(K) P190006.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR IS DECEASED. THIS INFORMATION CAME FROM THE PHYSICIAN'S OFFICE, AND NO ADDITIONAL DETAILS WERE PROVIDED. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030558 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 4101 AX1T066132 10810005340455

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Death