BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXONICS

    MDR report key: 23436536 · Received October 31, 2025

    Report

    Report Number
    3002968685-2025-00173
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    December 17, 2025
    Report Date
    January 14, 2026
    Manufacturer
    AXONICS, INC
    Product Code
    EZW
    UDI-DI
    10810005340066
    PMA / PMN Number
    P180046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF EVENTS WITHIN THE AXONICS COMPLAINT HANDLING SYSTEM IDENTIFIED THIS RECORD AS REQUIRING REMEDIATION, INCLUDING REPORTING AND SUBMISSION OF AN INITIAL EMDR PER APPLICABLE CRITERIA. BOSTON SCIENTIFIC HAS OPENED A NONCONFORMING EVENTS & PREVENTION (00170822) INVESTIGATION TO DETERMINE THE ROOT CAUSE FOR WHY AN INITIAL EMDR WAS NOT PREVIOUSLY SUBMITTED TO THE FDA IN ACCORDANCE WITH AXONICS ESTABLISHED MDR REPORTING PROCESS AND FDA ADVERSE EVENT REPORTING REQUIREMENTS. INFORMATION GAINED THROUGH THESE INVESTIGATION EFFORTS WILL BE UTILIZED TO DETERMINE ROOT CAUSE AND IMPLEMENT APPROPRIATE PREVENTIVE ACTION(S), AS NECESSARY.

    Additional Manufacturer Narrative · 0

    A REVIEW OF EVENTS WITHIN THE AXONICS COMPLAINT HANDLING SYSTEM IDENTIFIED THIS RECORD AS REQUIRING REMEDIATION, INCLUDING REPORTING AND SUBMISSION OF AN INITIAL EMDR PER APPLICABLE CRITERIA. BOSTON SCIENTIFIC HAS OPENED A NONCONFORMING EVENTS & PREVENTION (00170822) INVESTIGATION TO DETERMINE THE ROOT CAUSE FOR WHY AN INITIAL EMDR WAS NOT PREVIOUSLY SUBMITTED TO THE FDA IN ACCORDANCE WITH AXONICS ESTABLISHED MDR REPORTING PROCESS AND FDA ADVERSE EVENT REPORTING REQUIREMENTS. INFORMATION GAINED THROUGH THESE INVESTIGATION EFFORTS WILL BE UTILIZED TO DETERMINE ROOT CAUSE AND IMPLEMENT APPROPRIATE PREVENTIVE ACTION(S), AS NECESSARY.

    Description of Event or Problem · 0

    THE PATIENT WAS PRESCRIBED ANTIBIOTICS DUE TO A BLADDER INFECTION, TENDERNESS, NERVE INFLAMMATION, AND PAIN AT THE POCKET SITE.

    Description of Event or Problem · 0

    SEE SECTION H, NUMBER 11, FOR CORRECTION UPDATES.

    Description of Event or Problem · 0

    SEE SECTION H, NUMBER 11, FOR CORRECTION UPDATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55701 AXONICS NEUROSTIMULATOR EZW AXONICS, INC 1101 10810005340066

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown