BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 10461356 · Received August 27, 2020

    Report

    Report Number
    3002968685-2020-00069
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    July 28, 2020
    Report Date
    August 27, 2020
    Product Code
    EZW
    UDI-DI
    10810005340127
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEVELOPED EDEMA AT THE INSERTION SITE. PATIENT HAD PNE LEADS REMOVED AND DISCARDED AND WAS TREATED. PATIENT HAS FULLY RECOVERED AND WILL BE RECEIVING A FULL IMPLANT ON (B)(6) 2020.

    Description of Event or Problem · 1

    THE COMPANY WAS MADE AWARE ON (B)(6) 2020 THAT A PATIENT HAD DEVELOPED AN EDEMA AT THE PNE INSERTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927052 AXONICS NEUROSTIMULATOR EZW 1901 10810005340127

    Patients

    Seq Age Sex Outcome Treatment
    1