BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 23118996 · Received September 22, 2025

    Report

    Report Number
    2124215-2025-65388
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 28, 2025
    Report Date
    January 9, 2026
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340066
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. THIS REPORT IS BEING FILED FOR A CORRECTION TO FIELD H6.

    Additional Manufacturer Narrative · 0

    PRODUCT CODE (D2B): ADDITIONAL PRODUCT CODE QON. PREMARKET/510(K) # (G4): ADDITIONAL PREMARKET/510(K) # P190006.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION FOR THEIR INS. THE PATIENT WAS FRUSTRATED THAT THEY COULD NOT HOLD A CHARGE FOR THE ADVERTISED AMOUNT OF TIME. THE PATIENT'S DEVICE WOULD NOT HOLD A CHARGE FOR 30 DAYS AND IT WOULD TAKE HOURS TO CHARGE. THE PATIENT SWITCHED TO A NON-RECHARGE INS. THE PATIENT IS EXPECTED TO FULLY RECOVER. THE CLINICAL SPECIALIST LEFT THE PATIENT A VOICEMAIL TO FOLLOW UP AND WILL UPDATE WHEN THEY HEAR BACK FROM THEM. THE CLINICAL SPECIALIST CALLED THE PATIENT AGAIN AND THE PATIENT STATED THEY ARE DOING GREAT SINCE THE INS CHANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION FOR THEIR INS. THE PATIENT WAS FRUSTRATED THAT THEY COULD NOT HOLD A CHARGE FOR THE ADVERTISED AMOUNT OF TIME. THE PATIENT'S DEVICE WOULD NOT HOLD A CHARGE FOR 30 DAYS AND IT WOULD TAKE HOURS TO CHARGE. THE PATIENT SWITCHED TO A NON-RECHARGE INS. THE PATIENT IS EXPECTED TO FULLY RECOVER. THE CLINICAL SPECIALIST LEFT THE PATIENT A VOICEMAIL TO FOLLOW UP AND WILL UPDATE WHEN THEY HEAR BACK FROM THEM. THE CLINICAL SPECIALIST CALLED THE PATIENT AGAIN AND THE PATIENT STATED THEY ARE DOING GREAT SINCE THE INS CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200653 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 AX1H158408 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention| H