BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 13064170 · Received December 22, 2021

    Report

    Report Number
    3002968685-2021-00053
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    November 24, 2021
    Report Date
    December 29, 2021
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340066
    PMA / PMN Number
    P180046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SEE SECTION D, H3, H4 AND H6 FOR UPDATES.

    Description of Event or Problem · 0

    THE COMPANY WAS MADE AWARE ON (B)(6) 2021 THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 DUE TO HIGH IMPEDANCE.

    Description of Event or Problem · 0

    THE COMPANY WAS MADE AWARE ON 11/23/2021 THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 DUE TO HIGH IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1961358 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 2201 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown