BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 14681968 · Received June 13, 2022

    Report

    Report Number
    3002968685-2022-00056
    Event Type
    Injury
    Date Received
    June 13, 2022
    Date of Event
    May 16, 2022
    Report Date
    June 13, 2022
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340066
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE COMPANY WAS MADE AWARE THAT A PATIENT UNDERWENT AN EXPLANT SURGERY DUE TO PAIN.

    Description of Event or Problem · 0

    SEE SECTION H, NUMBER 6 FOR INVESTIGATION UPDATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249943 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown