BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 11703993 · Received April 21, 2021

    Report

    Report Number
    3002968685-2021-00015
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 25, 2021
    Report Date
    April 21, 2021
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340141
    PMA / PMN Number
    P190006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS MADE AWARE ON (B)(6) 2021 THAT A PATIENT HAD A REVISION SURGERY DUE TO LEAD MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601932 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1201 10810005340141

    Patients

    Seq Age Sex Outcome Treatment
    1