BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 11621841 · Received April 6, 2021

    Report

    Report Number
    3002968685-2021-00012
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 7, 2021
    Report Date
    May 21, 2021
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340066
    PMA / PMN Number
    P180046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    SEE SECTION H, NUMBER 3 FOR INVESTIGATION UPDATES.

    Description of Event or Problem · 0

    SEE H6 FOR INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THE COMPANY WAS MADE AWARE ON (B)(6) 2021 THAT A PATIENT¿S NEUROSTIMULATOR (IPG) WAS REPLACED FOR A BATTERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519280 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1