BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 14660624 · Received June 10, 2022

    Report

    Report Number
    3002968685-2022-00058
    Event Type
    Injury
    Date Received
    June 10, 2022
    Date of Event
    May 16, 2022
    Report Date
    August 24, 2022
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC
    Product Code
    EZW
    UDI-DI
    10810005340066
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    SEE SECTION H, NUMBER 6 FOR INVESTIGATION UPDATE.

    Description of Event or Problem · 0

    SECTION D SUSPECT MEDICAL DEVICE: ADDED SERIAL NUMBER, MODEL NUMBER, EXP DATE, AND UDI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289578 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC 1101 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown