BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOMEMS

    MDR report key: 23350694 · Received October 21, 2025

    Report

    Report Number
    MW5177749
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    December 17, 2024
    Report Date
    October 16, 2025
    Manufacturer
    ABBOTT MEDICAL/ ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.
    Product Code
    MOM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    HAD CARDIOMEMS IMPLANTED AT (B)(6) HOSPITAL IN (B)(6) 2024 WHEN I WAS HOSPITALIZED THAT MY HUSBAND AT THE TIME SIGNED PAPERWORK ON THAT IS ON THE RECALL Z-0989-2025 PMA NUMBER P100045 UDI-DI CODE (B)(4) IN (B)(6) 2024 I HAD A BUNCH OF TIGHTNESS IN MY CHEST AND WAS VERY HARD TO BREATHE I HAD TO CALL AN AMBULANCE AND BE TAKEN TO THE HOSPITAL WHERE I WAS THERE FOR MOST OF THE DAY. MY THEN HUSBAND IS REFUSING TO HAND OVER THE PAPERWORK HE FILLED OUT FOR THIS DEVICE THAT WAS IMPLANTED BACK IN (B)(6) AND I STILL TO THIS DAY HAVE THE DEVICE THAT NEEDS REPLACEMENT. I BELIEVE SOMEONE HE KNOWS HAS ACCESS TO THIS DEVICE AND WAS PURPOSELY MESSING WITH THE SYSTEM WITH SOMEONE THAT USED TO WORK AT THE HOSPITAL WHEN I HAD THE DEVICE IMPLANTED IN (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2730412 CARDIOMEMS SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ABBOTT MEDICAL/ ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC. MN6000 CM30000

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Hospitalization| O| L