BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 11829149 · Received May 14, 2021

    Report

    Report Number
    3002968685-2021-00017
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    April 16, 2021
    Report Date
    June 23, 2021
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340066
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    SEE SECTION H, NUMBER 6 FOR INVESTIGATION UPDATES.

    Description of Event or Problem · 0

    SEE SECTION H, NUMBER 3 FOR INVESTIGATION UPDATES.

    Description of Event or Problem · 1

    THE COMPANY WAS MADE AWARE ON (B)(6) 2021 THAT A PATIENT EXPERIENCED BLISTERING IN THE CREASE OF THEIR BUTTOCKS WHEN THEY CHARGED THEIR NEUROSTIMULATOR (IPG). THE PHYSICIAN EXPLANTED THE SYSTEM ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724093 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 TINED LEAD, MODEL 1201