BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 18677831 · Received February 9, 2024

    Report

    Report Number
    3004936110-2024-00190
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    January 31, 2024
    Report Date
    February 29, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE ANALYSIS RESULTS ARE AVAILABLE BECAUSE THE DEVICE REMAINS IMPLANTED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THAT NO NON-CONFORMANCES WERE IDENTIFIED THAT ARE RELATED TO THE REPORTED EVENT. PER THE IFU, 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

    ON (B)(6) 2024 A RIGHT HEART CATHETERIZATION WAS PERFORMED. THE PRIMARY REASON FOR THE RIGHT HEART CATHETERIZATION WAS NOT TO CHECK THE SENSOR. HOWEVER, AS A RIGHT HEART CATHETERIZATION WAS BEING PERFORMED THE SENSOR WAS CHECKED ANYWAY. THE SENSOR WAS RECALIBRATED AND THE MEAN WAS INCREASED BY 16.2MMHG. ACCURATE READINGS WERE OBSERVED UNDER THE MANUFACTURER'S PATIENT CARE NETWORK DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242478 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000 8869410 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention