BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 18426938 · Received January 2, 2024

    Report

    Report Number
    3004936110-2023-01843
    Event Type
    Injury
    Date Received
    January 2, 2024
    Date of Event
    December 11, 2023
    Report Date
    March 4, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE ANALYSIS RESULTS ARE AVAILABLE BECAUSE THE DEVICE REMAINS IMPLANTED. THE REPORTED ISSUE WAS INVESTIGATED BUT CANNOT BE CONCLUSIVELY CONFIRMED AT THIS TIME AS A CALIBRATION WAS NOT PERFORMED. AS REPORTED, NO FURTHER ISSUE WAS REPORTED. 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 32.92-MHZ, AND 33.67-MHZ DURING THE REVIEW OF THE APPLICABLE READING(S). A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED 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

    A RIGHT HEART CATHETERIZATION WAS PERFORMED TO CONFIRM THE VALIDITY OF THE PRESSURE SENSOR READINGS. THE SENSOR PRESSURES MATCHED THE PRESSURE FROM THE CATHETER AND THE SENSOR WAS NOT RECALIBRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855703 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000 6963040 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention