BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 22146146 · Received June 4, 2025

    Report

    Report Number
    2124215-2025-36809
    Event Type
    Injury
    Date Received
    June 4, 2025
    Date of Event
    May 15, 2025
    Report Date
    July 24, 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
    UT, 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 WAS EXPERIENCING A STAPH INFECTION, AND THE PHYSICIAN WAS GOING TO REMOVE THE DEVICE. IT WAS NOTED THERE WAS PUS AT THE INCISION SITE. THE PHYSICIAN PRESCRIBED ANTIBIOTICS AND THE DEVICE WAS REMOVED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS NEUROSTIMULATOR WAS EXPERIENCING A STAPH INFECTION, AND THE PHYSICIAN WAS GOING TO REMOVE THE DEVICE. IT WAS NOTED THERE WAS PUS AT THE INCISION SITE. THE PHYSICIAN PRESCRIBED ANTIBIOTICS AND THE DEVICE WAS REMOVED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81054 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 4101 AX1T063258 10810005340455

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| H