BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 20978035 · Received December 19, 2024

    Report

    Report Number
    3002968685-2024-00302
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    December 5, 2024
    Report Date
    February 14, 2025
    Manufacturer
    AXONICS, INC
    Product Code
    EZW
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SEE SECTION D, NUMBER 4 FOR CATALOG AND UDI UPDATES. SEE SECTION H, NUMBER 6 FOR INVESTIGATION UPDATES.

    Description of Event or Problem · 0

    THE PNE WIRE BROKE DURING PNE TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2283174 AXONICS NEUROSTIMULATOR EZW AXONICS, INC 1701 AK1LB31002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention