BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 11860936 · Received May 20, 2021

    Report

    Report Number
    3002968685-2021-00019
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    April 22, 2021
    Report Date
    June 18, 2021
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340066
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    SEE SECTION H. NUMBER 6 FOR INVESTIGATION UPDATES.

    Description of Event or Problem · 1

    THE COMPANY WAS MADE AWARE ON (B)(6) 2021 THAT A PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE NEUROSTIMULATOR (IPG) AND TINED LEAD DUE TO PAIN AND UNCOMFORTABLE SENSATIONS AFTER FALLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751735 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 TINED LEAD, MODEL 1201