BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 17180690 · Received June 22, 2023

    Report

    Report Number
    3004936110-2023-00657
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    June 7, 2023
    Report Date
    September 28, 2023
    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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: NO DEVICE ANALYSIS RESULTS ARE AVAILABLE BECAUSE THE DEVICE REMAINS IMPLANTED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND RULED OUT THE POSSIBILITY OF A MANUFACTURING RELATED ISSUE CAUSING OR CONTRIBUTING TO THE REPORTED COMPLAINT ISSUE. PER THE INSTRUCTIONS FOR USE, 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

    IT WAS REPORTED THAT RIGHT HEART CATHETERIZATION WAS PERFORMED ON (B)(6) 2023. SIDE BY SIDE COMPARISON OF SENSOR READINGS WERE NOT PERFORMED AND THE SENSOR WAS NOT RECALIBRATED AT THE TIME OF THE PROCEDURE. ON (B)(6) 2023 THE SITE REQUESTED THAT A RECALIBRATION BE PERFORMED VIA THE PATIENT NETWORK DATABASE USING DATA FROM THE RIGHT HEART CATHETERIZATION. THE SENSOR BASELINE WAS INCREASED BY 20 MMHG.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION CONFIRMED THAT THE RIGHT HEART CATHETERIZATION WAS PERFORMED PRIMARILY FOR REASONS UNRELATED TO THE PRESSURE SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133969 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000 6330537 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Hospitalization| R