BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 22323540 · Received June 24, 2025

    Report

    Report Number
    2124215-2025-39594
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    May 27, 2025
    Report Date
    January 14, 2026
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340141
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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. ADDITIONAL INFORMATION: IMPACT CODES (H6).

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON. PREMARKET / 510(K) # (G4)- ADDITIONAL PREMARKET/510(K) P190006. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. XRAYS WERE PROVIDED WITH NO COMMENTARY FROM THE EXPERT. A DHR REVIEW WAS PERFORMED AND FOUND NO NON-CONFORMANCES. ALL ESTABLISHED SPECIFICATIONS AND CRITERIA FOR RELEASE WERE MET. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. THE DEVICE WAS UNAVAILABLE FOR EVALUATION. KNOWN INHERENT RISK WAS CHOSEN AS A CONCLUSION CODE DUE TO REPORTED ISSUES BEING COVERED IN RISK DOCUMENTATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR HAD A REVISION SURGERY DUE TO LEAD MIGRATION. THE PATIENT IS DOING REALLY WELL FOLLOWING THE REVISION. THERE WERE NO COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR HAD A REVISION SURGERY DUE TO LEAD MIGRATION. THE PATIENT IS DOING REALLY WELL FOLLOWING THE REVISION. THERE WERE NO COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR HAD A REVISION SURGERY DUE TO LEAD MIGRATION. THE PATIENT IS DOING REALLY WELL FOLLOWING THE REVISION. THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1971641 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 1201 AL1K532914 10810005340141

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention| H