BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 17109990 · Received June 12, 2023

    Report

    Report Number
    3004936110-2023-00534
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    May 23, 2023
    Report Date
    June 28, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509800
    PMA / PMN Number
    P100045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: 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

    A RIGHT HEART CATHETERIZATION WAS PERFORMED PRIMARILY FOR REASONS UNRELATED TO THE PRESSURE SENSOR. THE SENSOR PRESSURE WERE COMPARED TO THE PRESSURES FROM THE RIGHT HEART CATHETER DURING THE PROCEDURE. THE SENSOR WAS RECALIBRATED AND THE MEAN WAS DECREASED BY 10 MMHG. READINGS WERE OBSERVED UNDER THE MANUFACTURER'S PATIENT CARE NETWORK DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482503 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000 8791122 05414734509800

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention