BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 22299985 · Received June 20, 2025

    Report

    Report Number
    2124215-2025-39154
    Event Type
    Injury
    Date Received
    June 20, 2025
    Date of Event
    May 25, 2025
    Report Date
    September 15, 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
    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 Manufacturer Narrative · 0

    PRODUCT CODE (D2B) - ADDITIONAL PRODUCT CODE QON PREMARKET / 510(K) # (G4) - ADDITIONAL PREMARKET / 510(K) # P190006 UDI FOR CONCOMITANT PRODUCT, TINED LEAD: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOR A POSSIBLE INFECTION POST-IMPLANT. THE POCKET HAD OPENED. THE PATIENT UNDERWENT EXPLANT SURGERY OF THEIR NEUROSTIMULATOR IMPLANT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOR A POSSIBLE INFECTION POST-IMPLANT AND THE POCKET OPENED. THE PATIENT UNDERWENT EXPLANT SURGERY OF THEIR NEUROSTIMULATOR IMPLANT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202254 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 4101 AX1T058572 10810005340455

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Required Intervention| H TINED LEAD, 1201, AL1N241931.| TINED LEAD, 1201, AL1N241931.