BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 22146965 · Received June 4, 2025

    Report

    Report Number
    2124215-2025-36808
    Event Type
    Injury
    Date Received
    June 4, 2025
    Date of Event
    May 15, 2025
    Report Date
    July 30, 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
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: QON. ADDITIONAL PREMARKET/510K: P190006.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: QON. ADDITIONAL PREMARKET/510K: P190006.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR HAD THE DEVICE REMOVED DUE TO INEFFECTIVE TREATMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR HAD THE DEVICE REMOVED DUE TO INEFFECTIVE TREATMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937686 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 4101 AX1T006339 10810005340455

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization| R TINED LEAD 1201,AL1W911768.| TINED LEAD 1201,AL1W911768.