BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 22329911 · Received June 25, 2025

    Report

    Report Number
    2124215-2025-39640
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 30, 2025
    Report Date
    December 10, 2025
    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
    KY, 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. THIS REPORT IS BEING FILED FOR A CORRECTION TO FIELD H6. 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. A DEVICE WAS NOT RETURNED, AND PICTURES WERE NOT PROVIDED RESULTING IN AN INABILITY TO ANALYZE THE DEVICE AND IDENTIFY IF A MALFUNCTION OCCURRED. BASED ON THE INFORMATION AVAILABLE, THE PATIENT WAS HAVING DIFFICULT CHARGING THEIR DEVICE BECAUSE THEY WERE NOT FLEXIBLE ENOUGH TO REACH THE IMPLANT SITE, SO THEY WERE REPLANTED WITH A NON-RECHARGEABLE IPG. CAUSE COULD NOT BE ESTABLISHED FOR THE DIFFICULTY THE PATIENT WAS HAVING WITH CHARGING THEIR DEVICE, 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 WAS REPORTED THAT THE PATIENT HAD THEIR NEUROSTIMULATOR REVISED DUE TO THE INABILITY TO CHARGE DUE TO DEXTERITY ISSUES. THE PATIENT TRIED REPROGRAMMING AND HAD ASSISTANCE WITH RECHARGING, BUT THEIR NEUROSTIMULATOR IMPLANT WAS REPLACED WITH A RECHARGE FREE ONE. THE PATIENT IS PROGRAMMED WELL. THE PATIENT WAS REPORTED TO BE DOING FINE AND HAD NO ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD THEIR NEUROSTIMULATOR REVISED DUE TO THE INABILITY TO CHARGE DUE TO DEXTERITY ISSUES. THE PATIENT TRIED REPROGRAMMING AND HAD ASSISTANCE WITH RECHARGING, BUT THEIR NEUROSTIMULATOR IMPLANT WAS REPLACED WITH A RECHARGE FREE ONE. THE PATIENT IS PROGRAMMED WELL. THE PATIENT WAS REPORTED TO BE DOING FINE AND HAD NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2484454 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 AX1H167559 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention| H