BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 22288593 · Received June 18, 2025

    Report

    Report Number
    2124215-2025-37640
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    May 20, 2025
    Report Date
    November 24, 2025
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340141
    PMA / PMN Number
    P180046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 VISUAL INSPECTION SHOWED A DEFORMED LEAD. FURTHER INVESTIGATION SHOWED THAT LEAD HAD OPEN IMPEDANCES, INDICATING WIRE FRACTURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. THIS INVESTIGATION IS ASSIGNED THE OVERALL CONCLUSION CODE OF CAUSE NOT ESTABLISHED. ALTHOUGH DEVICE WAS RETURNED AND ANALYSIS CONFIRMED FRACTURE DAMAGE, THIS CONCLUSION WAS SELECTED AS THE INFORMATION AVAILABLE WAS INSUFFICIENT IN DETERMINING THE CAUSE OF THE DAMAGE. HOWEVER, IT IS MOST PROBABLE THAT THE DAMAGE IDENTIFIED DURING ANALYSIS LIKELY CONTRIBUTED TO HIGH IMPEDANCE AND RED LIGHT AS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD A RED LIGHT ON THEIR REMOTE CONTROL. IT WAS THEN DISCOVERED THE PATIENT HAD OPEN (HIGH) IMPEDANCES ON ALL FOUR ELECTRODES. THE PATIENT'S LEAD WAS TESTED WITH THE STIM CLIP TO ENSURE THERE WERE OPEN IMPEDANCES PRIOR TO REMOVING IT. THERE WAS A NOTICEABLE BEND IN THE LEAD AFTER IT WAS REMOVED. THE PATIENT UNDERWENT REVISION SURGERY OF THEIR TINED LEAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT IS DOING WELL.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD A RED LIGHT ON THEIR REMOTE CONTROL. IT WAS THEN DISCOVERED THE PATIENT HAD OPEN (HIGH) IMPEDANCES ON ALL FOUR ELECTRODES. THE PATIENT'S LEAD WAS TESTED WITH THE STIM CLIP TO ENSURE THERE WERE OPEN IMPEDANCES PRIOR TO REMOVING IT. THERE WAS A NOTICEABLE BEND IN THE LEAD AFTER IT WAS REMOVED. THE PATIENT UNDERWENT REVISION SURGERY OF THEIR TINED LEAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724148 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 1201 AL1R841180 10810005340141

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Hospitalization| R