BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 18367359 · Received December 20, 2023

    Report

    Report Number
    3004936110-2023-01882
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 27, 2023
    Report Date
    February 13, 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SENSOR WAS REVIEWED AND FOUND OUTSIDE OF THE TOLERANCE FOR CM MEAN. THE CAUSE IS INCONCLUSIVE AT THIS TIME AND IS UNDER INVESTIGATION. 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 33.6, 33.8, AND 33.7 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 PRIMARILY FOR REASONS UNRELATED TO THE PRESSURE SENSOR. THE SENSOR PRESSURE READINGS WERE COMPARED TO THE PRESSURE READINGS FROM THE CATHETER. THE SENSOR WAS RECALIBRATED AND THE BASELINE WAS DECREASE BY 13MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2118815 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000 8915510 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention