BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 22963227 · Received September 4, 2025

    Report

    Report Number
    2124215-2025-61637
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    July 14, 2025
    Report Date
    November 23, 2025
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340455
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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)(4).

    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). SUPPLEMENTAL RECORD BEING SUBMITTED FOR CORRECTION TO (F10): F1903 - DEVICE EXPLANTATION.

    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 ANALYSIS OF THE PRODUCT COULD BE PERFORMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. BASED ON THE INFORMATION AVAILABLE THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LACK OF EFFECT WITH THE DEVICE. THE PATIENT HAD THE DEVICE REMOVED. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LACK OF EFFECT WITH THE DEVICE. THE PATIENT HAD THE DEVICE REMOVED. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LACK OF EFFECT WITH THE DEVICE. THE PATIENT HAD THE DEVICE REMOVED. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331322 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 4101 AX1T054047 10810005340455

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown Required Intervention| H TINED LEAD (1201) SN: (B)(6).