BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 24242800 · Received February 2, 2026

    Report

    Report Number
    2124215-2026-05970
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    November 1, 2025
    Report Date
    May 29, 2026
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340066
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THE PATIENT HAD SURGERY TO REVISE THEIR NEUROSTIMULATOR. INITIALLY, THE PATIENT HAD DIFFICULTY WITH KEEPING THEIR IMPLANT CHARGED. THE PATIENT WAS EDUCATED ON CHARGING STEPS, BUT THE PATIENT MOVED FORWARD WITH SWAPPING THEIR NEUROSTIMULATOR FOR A NON-RECHARGE VERSION. THE PATIENT IS DOING GREAT. THEY HAVE NOT HAD ANY EPISODES OF INCONTINENCE SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17087 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1