BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 13003041 · Received December 14, 2021

    Report

    Report Number
    3002968685-2021-00052
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    November 22, 2021
    Report Date
    December 14, 2021
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340134
    PMA / PMN Number
    P190006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE COMPANY WAS MADE AWARE ON (B)(6) 2021 THAT A PHYSICIAN DISCOVERED AN INFECTION AT THE LEAD SITE RESULTING FROM THE BASIC TRIAL.

    Description of Event or Problem · 0

    THE COMPANY WAS MADE AWARE ON (B)(6) 2021 THAT A PHYSICIAN DISCOVERED AN INFECTION AT THE LEAD SITE RESULTING FROM THE BASIC TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1903178 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1701 10810005340134

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown