BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 22328810 · Received June 25, 2025

    Report

    Report Number
    2124215-2025-39490
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 29, 2025
    Report Date
    April 10, 2026
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340066
    PMA / PMN Number
    P180046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 STOPPED USING THEIR DEVICE DUE TO PERCEIVED LACK OF EFFICACY. THE PATIENT ALSO NOTED THEY WERE UNAWARE THE DEVICE REQUIRED CHARGING. THE PATIENT WAS SEEN IN CLINIC AND DEVICE COULD NOT BE INTERROGATED. A SURGICAL PROCEDURE WAS SCHEDULED TO REPLACE THE DEVICE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367801 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 AX1H162150 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female 1201, AL1T801237.