BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 23359989 · Received October 22, 2025

    Report

    Report Number
    2124215-2025-73452
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    September 25, 2025
    Report Date
    December 17, 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
    TN, 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. UDI FOR CONCOMITANT PRODUCT, TINED LEAD: (B)(6). CORRECTION: BLOCK H6. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. A DEVICE WAS NOT RETURNED RESULTING IN AN INABILITY TO ANALYZE THE DEVICE AND IDENTIFY IF A MALFUNCTION OCCURRED. BASED ON THE INFORMATION AVAILABLE, IT CANNOT BE CONFIRMED WHAT THE CAUSE WAS. BASED ON THE DHR, THE DEVICE WAS CONFIRMED TO MEET SPECIFICATIONS PRIOR TO SHIPMENT THEREFORE CONCLUDING MANUFACTURING WAS NOT RELATED TO THE REPORTED EVENT. IF THE FURTHER INFORMATION IS RECEIVED THE INVESTIGATION WILL BE RE-OPENED. WITHOUT A RETURNED PRODUCT AVAILABLE FOR ANALYSIS AND BASED ON THIS INVESTIGATION, A CLEAR PROBABLE CAUSE FOR THE EVENT CANNOT BE ESTABLISHED; THEREFORE, THE CONCLUSION CODE OF CAUSE NOT ESTABLISHED HAS BEEN CHOSEN. BASED ON THE INFORMATION AVAILABLE THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED.

    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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A SURGICAL PROCEDURE TO REVISE THE NEUROSTIMULATOR AND TINED LEAD DUE TO FREQUENT CHARGING AND THERAPY NOT WORKING WELL. THE PATIENT HAD A FULL SYSTEM SWAP AND IS REPORTED TO BE DOING GREAT AND HAPPY WITH RESULTS POST- REVISION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A SURGICAL PROCEDURE TO REVISE THE NEUROSTIMULATOR AND TINED LEAD DUE TO FREQUENT CHARGING AND THERAPY NOT WORKING WELL. THE PATIENT HAD A FULL SYSTEM SWAP AND IS REPORTED TO BE DOING GREAT AND HAPPY WITH RESULTS POST- REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401976 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 AX1H152490 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Hospitalization| R TINED LEAD, 1201, (B)(6).