BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 12096565 · Received June 30, 2021

    Report

    Report Number
    3002968685-2021-00027
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 3, 2021
    Report Date
    July 16, 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
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO H4 MFG DATE AND D4 EXPIRATION DATE.

    Description of Event or Problem · 0

    SEE SECTION H, NUMBER 6 FOR INVESTIGATION UPDATES.

    Description of Event or Problem · 1

    THE COMPANY WAS MADE AWARE ON 06/03/2021 THAT THE PHYSICIAN PERFORMED A LEAD REVISION SURGERY DUE TO MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988548 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1201 10810005340141

    Patients

    Seq Age Sex Outcome Treatment
    1