BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 14436513 · Received May 19, 2022

    Report

    Report Number
    3002968685-2022-00046
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    April 21, 2022
    Report Date
    July 22, 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
    MT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE COMPANY WAS MADE AWARE THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO THE NEUROSTIMULATOR (IPG) MIGRATING.

    Description of Event or Problem · 0

    SEE UPDATES IN H3.

    Description of Event or Problem · 0

    SEE SECTION H, NUMBER 6 FOR INVESTIGATION UPDATES.

    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
    344270 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown