BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 22322032 · Received June 24, 2025

    Report

    Report Number
    2124215-2025-39606
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    May 27, 2025
    Report Date
    August 28, 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
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. THIS REPORT IS BEING SUBMITTED TO UPDATE THE EVALUATION CONCLUSION CODES (H6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO DAYS AFTER THE INITIAL IMPLANT, THE PATIENT VISITED THE EMERGENCY ROOM DUE TO INFECTION AND IMPLANT PAIN. THE PATIENT WAS IMPLANTED FOR URINARY RETENTION. THE PATIENT WAS PRESCRIBED ANTIBIOTICS BUT EVENTUALLY HAD AN EXPLANT SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO DAYS AFTER THE INITIAL IMPLANT, THE PATIENT VISITED THE ER DUE TO INFECTION AND IMPLANT PAIN. THE PATIENT WAS IMPLANTED FOR URINARY RETENTION. THE PATIENT WAS PRESCRIBED ANTIBIOTICS BUT EVENTUALLY HAD AN EXPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427690 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 4101 AX1T051468 10810005340455

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Unknown Hospitalization| R