BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 18230564 · Received November 29, 2023

    Report

    Report Number
    3004936110-2023-01754
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    November 9, 2023
    Report Date
    February 5, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE ANALYSIS RESULTS ARE AVAILABLE BECAUSE THE DEVICE REMAINS IMPLANTED. A REVIEW OF THE INFORMATION PROVIDED WAS PERFORMED, AND THE SENSOR WAS WITHIN THE TOLERANCE FOR CM MEAN; THEREFORE, THE REPORTED MALFUNCTION IS UNCONFIRMED. THIS REPORTED EVENT WAS NOT INVESTIGATED FOR POSSIBLE INACCURATE READING, AS IT WAS INDICATED IN THE EVENT DESCRIPTION THAT IT WAS RESOLVED WITH STANDARD TROUBLESHOOTING. A REVIEW OF THE DHR WAS PERFORMED AND PER ENGINEERING REVIEW, THERE WAS NO ADVERSE IMPACT TO PRODUCT OR EVIDENCE OF RELATION TO THE EVENT REPORTED. 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

    ON (B)(6) 2023 IT WAS CONFIRMED THE SENSOR TRANSMITTED A DAMPENED WAVEFORM READING. ON (B)(6) 2023 A RIGHT HEART CATHETERIZATION WAS PERFORMED FOR REASONS UNRELATED TO THE CARDIOMEMS DEVICE AND THE SENSOR READINGS WERE COMPARED TO THE READINGS FROM THE CATHETER. THE PRESSURES FROM THE SENSOR MATCHED THE PRESSURES OBTAINED FROM THE CATHETER AND THE SENSOR WAS NOT RECALIBRATED. THE WAVEFORM OBTAINED FROM THE SENSOR WAS REPORTED TO BE SLIGHTLY MORE DAMPENED IN APPEARANCE THAN THE WAVEFORM FROM THE RRIGHT HEART CATHETER. THE PHYSICIAN IS CURRENTLY MONITORING THE PATIENT AND THE SENSOR READINGS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718382 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000 8152631 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male