BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 24521284 · Received March 5, 2026

    Report

    Report Number
    3004936110-2026-00287
    Event Type
    Injury
    Date Received
    March 5, 2026
    Date of Event
    January 23, 2026
    Report Date
    April 2, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE ANALYSIS RESULTS ARE AVAILABLE BECAUSE THE DEVICE REMAINS IMPLANTED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND RULED OUT THE POSSIBILITY OF A MANUFACTURING RELATED ISSUE CAUSING OR CONTRIBUTING TO THE REPORTED COMPLAINT ISSUE. PER THE INSTRUCTIONS FOR USE, RIGHT HEART CATHETERIZATION IS REQUIRED FOR SYSTEM BASELINE (MEAN PRESSURE) CALIBRATION AND MAY BE NEEDED TO RECALIBRATE THE BASELINE (MEAN PRESSURE) IN ORDER TO CONTINUE TO USE THE SYSTEM.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO RIGHT HEART CATHETERIZATION WAS PERFORMED AND THE SENSOR WAS CALIBRATED BASED ON RIGHT HEART CATHETERIZATION NUMBERS FROM IMPLANT.

    Description of Event or Problem · 0

    A RIGHT HEART CATHETERIZATION WAS PERFORMED TO CONFIRM THE VALIDITY OF THE PRESSURE SENSOR READINGS. THE SENSOR WAS NOT RECALIBRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619212 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ABBOTT MEDICAL CM2000 10967644 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention