BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 22135545 · Received June 3, 2025

    Report

    Report Number
    2124215-2025-35136
    Event Type
    Injury
    Date Received
    June 3, 2025
    Date of Event
    May 6, 2025
    Report Date
    June 26, 2025
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340455
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION H6 PATIENT CODES: PAIN CODE UPDATED TO IMPLANT PAIN CODE. ADDITIONAL PRODUCT CODE: QON. ADDITIONAL PREMARKET/510K: P190006.

    Additional Manufacturer Narrative · 0

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

    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 WAS EXPERIENCING SITE PAIN AND FELT THE DEVICE WAS MOVING INSIDE THE POCKET. A POCKET REVISION WAS DONE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR WAS EXPERIENCING SITE PAIN AND FELT THE DEVICE WAS MOVING INSIDE THE POCKET. A POCKET REVISION WAS DONE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR WAS EXPERIENCING SITE PAIN AND FELT THE DEVICE WAS MOVING INSIDE THE POCKET. A POCKET REVISION WAS DONE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR WAS EXPERIENCING SITE PAIN AND FELT THE DEVICE WAS MOVING INSIDE THE POCKET. A POCKET REVISION WAS DONE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361841 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 4101 AX1T010136 10810005340455

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention| H