BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 18360834 · Received December 19, 2023

    Report

    Report Number
    3004936110-2023-01874
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    December 12, 2023
    Report Date
    March 7, 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
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SENSOR WAS REVIEWED AND WAS OUTSIDE OF TOLERANCE WAS FOUND FOR CM MEAN. THE RECALIBRATION WAS PERFORMED VIA MERLIN.NET LOGS AND NO FURTHER ISSUE WAS IDENTIFIED. THIS REPORTED EVENT WAS INVESTIGATED FOR POSSIBLE INACCURATE READING. BASED ON THE INFORMATION GIVEN AND BACKEND LOG ANALYSIS, IT WAS CONFIRMED THAT THE DEVICE WAS OPERATING WITHIN THE EXPECTED FREQUENCY RANGE OF 30-37.5 MHZ. THE SENSOR WAS OPERATING AT 34.32-MHZ, 34.79-MHZ, AND 35.23-MHZ DURING THE REVIEW OF THE APPLICABLE READING(S). 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.

    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 (B)(4). READINGS WERE OBSERVED UNDER THE MANUFACTURER'S PATIENT CARE NETWORK DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2205397 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000 7692302 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention