BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 22341838 · Received June 26, 2025

    Report

    Report Number
    2124215-2025-42509
    Event Type
    Injury
    Date Received
    June 26, 2025
    Date of Event
    June 5, 2025
    Report Date
    May 11, 2026
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340455
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. THERE ARE A FEW REPORTS OF UTI WHEN SACRAL NEUROMODULATION (SNM) IS USED. FROM DISCUSSIONS WITH CLINICAL EXPERTS, THERE IS NO KNOWN CAUSAL RELATIONSHIP WITH SNM. UTI IS A BACTERIAL INFECTION IN THE URINARY TRACT. THE SNM SYSTEM DOES NOT PHYSICALLY CONTACT THE URINARY TRACT AND HENCE THERE IS NO OBVIOUS MEANS FOR AN SNM SYSTEM TO INTRODUCE OR BE A CONDUIT FOR BACTERIA. BECAUSE THERE IS NO KNOWN CAUSAL RELATIONSHIP, RELEVANT MITIGATIONS ARE NOT EVIDENT. THE ISSUE IS INCLUDED IN THE ANALYSIS TO ALLOW FOR TRACKING AND ROUTINE RE-CONSIDERATION OF THE POTENTIAL FOR A CAUSAL RELATIONSHIP SHOULD OUTCOMES EXCEED EXPECTED REPORTS. THE CAUSE OF THE OF THE UTI COULD NOT BE ESTABLISHED, BUT IS A KNOWN INHERENT RISK OF THE DEVICE, THEREFORE, AN INVESTIGATION CONCLUSION CODE OF 'KNOWN INHERENT RISK OF DEVICE' WAS CHOSEN. THE REPORTED PATIENT SYMPTOM(S) ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    IT REPORTED THE PATIENT IS EXPERIENCING A UTI. IT IS NOT KNOWN IF THE PATIENT RECEIVED MEDICAL ATTENTION.

    Description of Event or Problem · 0

    IT REPORTED THE PATIENT IS EXPERIENCING A UTI. IT IS NOT KNOWN IF THE PATIENT RECEIVED MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379257 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 4101 AX1T039051 10810005340455

    Patients

    Seq Age Sex Outcome Treatment
    1