BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 10938233 · Received December 3, 2020

    Report

    Report Number
    3002968685-2020-00091
    Event Type
    Injury
    Date Received
    December 3, 2020
    Date of Event
    November 6, 2020
    Report Date
    December 2, 2020
    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 · 1

    THE COMPANY WAS MADE AWARE ON 11/09/2020 THAT THE PATIENT DEVELOPED AN INFECTION AT THE POCKET SITE. THE PHYSICIAN EXPLANTED THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402604 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 TINED LEAD, MODEL 1201