BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 19144437 · Received April 19, 2024

    Report

    Report Number
    3004936110-2024-00539
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    March 26, 2024
    Report Date
    May 9, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    PMA / PMN Number
    P100045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 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 A RIGHT HEART CATHETERIZATION WAS PERFORMED FOR A HEART TRANSPLANT WORKUP THE PATIENT WAS INACTIVE WITH CARDIOMEMS READINGS BETWEEN MID (B)(6) 2012 AND LATE (B)(6) 2023 SO THE PHYSICIAN WANTED TO ASSESS THE ACCURACY OF THE SENSOR DURING THE PROCEDURE. THE SENSOR PRESSURES WERE COMPARED TO THE PRESSURES FROM THE RIGHT HEART CATHETER AND THE SENSOR WAS RECALIBRATED. THE BASELINE CODE WAS DECREASED BY 15.3MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686716 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention