BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 11947233 · Received June 7, 2021

    Report

    Report Number
    3002968685-2021-00024
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 7, 2021
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340141
    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 05/11/2021 THAT THE PHYSICIAN EXPLANTED THE TINED LEAD DUE TO AN INFECTION. THE PATIENT WILL BE RESCHEDULED FOR A PERMANENT IMPLANT AFTER THE INFECTION HAS CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847271 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1201 10810005340141

    Patients

    Seq Age Sex Outcome Treatment
    1