BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NEUROMODULATOR INTERSTIM SYSTEM

    MDR report key: 22991327 · Received September 8, 2025

    Report

    Report Number
    MW5175666
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    February 21, 2025
    Report Date
    September 2, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE A TWO MEDTRONIC NEUROMODULATOR SINCE 2014. IN (B)(6) 2025, ONE OF MY MEDTRONIC NEUROMODULATORS WAS REPLACED WITH A NALU NEUROMODULATOR. DESPITE ASSURANCES FROM MEDTRONIC AND NALU REPS THAT THESE SYSTEMS ARE COMPATIBLE AND CAN'T COMMUNICATE, I HAVE FIRSTHAND EXPERIENCE WITH HOW THEY INTERACT BECAUSE I FEEL WHAT IS HAPPENING INSIDE MY BODY. SOMETIMES, THE TWO DEVICES FEEL GREAT TOGETHER, THOUGH THE EFFECTS ARE MOSTLY HARMFUL BECAUSE ONE DEVICE OVERPOWERS THE OTHER, LEADING TO DISCOMFORT. ADDITIONALLY, I AM INCREASINGLY WORRIED ABOUT HOW THESE INTERACTIONS AFFECT MY HEART AND OVERALL HEALTH. I WOULD APPRECIATE YOUR GUIDANCE AND ANY STEPS WE CAN TAKE TO ENSURE MY SAFETY AND WELL-BEING. I HAVE REPORTED THIS CONCERN WITH NO RESOLVE. REFERENCE REPORT: MW5175665.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2066331 MEDTRONIC NEUROMODULATOR INTERSTIM SYSTEM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other| S