BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 23260218 · Received October 9, 2025

    Report

    Report Number
    2124215-2025-70507
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    July 31, 2025
    Report Date
    March 11, 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
    OK, 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

    BLOCK D2B: PRODUCT CODE: ADDITIONAL PRODUCT CODE QON BLOCK D4: UDI FOR CONCOMITANT PRODUCT, TINED LEAD: (B)(4) BLOCK G4: PREMARKET / 510(K) #: ADDITIONAL PREMARKET/510(K) P190006 CORRECTION: BLOCK H6

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD A SURGICAL PROCEDURE TO REVISE THEIR NEUROSTIMULATOR AND TINED LEAD DUE TO A LEAD FRACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD THEIR (B)(6) 2025 NEUROSTIMULATOR AND TINED LEAD REVISION DUE TO A LEAD FRACTURE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2125921 AXONICS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 AX1H173454 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Hospitalization| R TINED LEAD, 1201, (B)(6).