BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 11784700 · Received May 6, 2021

    Report

    Report Number
    3002968685-2021-00016
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 18, 2021
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340141
    PMA / PMN Number
    P180046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE COMPANY WAS MADE AWARE ON (B)(6) 2021 THAT THE PHYSICIAN PERFORMED A REVISION SURGERY AND REPLACED THE LEAD.

    Description of Event or Problem · 1

    THE COMPANY WAS MADE AWARE ON (B)(6) 2021 OF A PATIENT THAT UNDERWENT A PROCEDURE IN WHICH THE POCKET WAS OPENED BY THE PHYSICIAN TO ASSESS AND RESOLVE A HIGH IMPEDANCE ISSUE. THE ISSUE WAS NOT RESOLVED AND THE PATIENT WILL LIKELY BE SCHEDULED FOR A LEAD REVISION. NO REVISION DATE HAS BEEN SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679379 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1201 10810005340141

    Patients

    Seq Age Sex Outcome Treatment
    1