BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS MODULATION TECHNOLOGIES, INC.

    MDR report key: 19626702 · Received June 26, 2024

    Report

    Report Number
    MW5156707
    Event Type
    Injury
    Date Received
    June 26, 2024
    Report Date
    June 25, 2024
    Manufacturer
    AXONICS, INC.
    Product Code
    EZW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT STATES SHE HAS AN AXONICS RE-CHARGEABLE DEVICE FOR 4 YEARS AND THE LEADS HAVE MOVED AND THE STIMULATION IS NOT WORKING PROPERLY. PATIENT ALSO MENTIONED SHE HAS A LOUD DRONE SOUND IN HER EAR. PATIENT MENTIONED SHE ALREADY REACHED OUT TO EARS, NOSE AND THROAT AND THEY HAVE NOT REFERRED HER TO A SURGEON YET. AGENT SUGGESTED CALLER SEEK OUT MEDICAL HCP TO ADDRESS THIS SYMPTOM. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFER TO ADDITIONAL DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828364 AXONICS MODULATION TECHNOLOGIES, INC. STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW AXONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown