BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 19201333 · Received April 29, 2024

    Report

    Report Number
    3004936110-2024-00558
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 24, 2024
    Report Date
    May 15, 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
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE ANALYSIS RESULTS ARE AVAILABLE BECAUSE THE DEVICE REMAINS IMPLANTED. 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. 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

    CLARIFYING INFORMATION WAS RECEIVED CONFIRMING THAT THE RIGHT HEART CATHETERIZATION WAS PART OF A WORK-UP FOR HEART TRANSPLANT NOT ROUTINE CARE POST HEART TRANSPLANT.

    Description of Event or Problem · 0

    A RIGHT HEART CATHETERIZATION WAS PERFORMED AS PART OF THE PATIENT'S STANDARD CARE POST HEART TRANSPLANT. THE SENSOR PRESSURES WERE COMPARED TO THE PRESSURES FROM THE RIGHT HEART CATHETER DURING THE PROCEDURE TO CONFIRM THE VALIDITY OF THE PRESSURE SENSOR READINGS. THE SENSOR WAS RECALIBRATED AND THE MEAN WAS INCREASED BY 20.7 MMHG. READINGS WERE OBSERVED UNDER THE MANUFACTURER'S PATIENT CARE NETWORK DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000921 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000 8915572 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention