BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 12096566 · Received June 30, 2021

    Report

    Report Number
    3002968685-2021-00026
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 4, 2021
    Report Date
    June 30, 2021
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340141
    PMA / PMN Number
    P180046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS MADE AWARE ON (B)(6) 2021 THAT DURING AN TRIAL TO PERMANENT CONVERSION PROCEDURE, THE TINED LEAD BROKE, CAUSING THE PHYSICIAN TO ABORT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988545 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1201 10810005340141

    Patients

    Seq Age Sex Outcome Treatment
    1