BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 18320398 · Received December 13, 2023

    Report

    Report Number
    3004936110-2023-01844
    Event Type
    Injury
    Date Received
    December 13, 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
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE INFORMATION PROVIDED WAS PERFORMED, AND THE SENSOR WAS WITHIN THE TOLERANCE FOR CM MEAN; THEREFORE, THE REPORTED MALFUNCTION IS UNCONFIRMED. AS REPORTED, 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 34.29-MHZ, 34.26-MHZ, AND 34.25-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 WAS RECALIBRATED AND THE MEAN WAS INCREASED BY 7.5 MMHG. READINGS WERE OBSERVED UNDER THE MANUFACTURER'S PATIENT CARE NETWORK DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326177 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000 8304702 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention