BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 14342630 · Received May 9, 2022

    Report

    Report Number
    3002968685-2022-00040
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 9, 2022
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340066
    PMA / PMN Number
    P180046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE COMPANY WAS MADE AWARE THAT A PATIENT UNDERWENT A REVISION DUE TO HIGH IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564856 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown