BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 16638089 · Received March 29, 2023

    Report

    Report Number
    3004936110-2023-00327
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    March 28, 2023
    Report Date
    June 22, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    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 DHR WAS PERFORMED AND RULED OUT THE POSSIBILITY OF A MANUFACTURING RELATED ISSUE CAUSING OR CONTRIBUTING TO THE REPORTED COMPLAINT ISSUE. 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 AND THE VALIDITY OF THE PRESSURE SENSOR READINGS WERE CHECKED. THE PRIMARY REASON FOR THE RIGHT HEART CATHETERIZATION WAS NOT TO CHECK THE SENSOR, BUT THE SENSOR WAS CHECKED REGARDLESS. THE SENSOR WAS RECALIBRATED AND THE MEAN WAS INCREASED BY 16.8MMHG. ACCURATE READINGS WERE OBSERVED UNDER THE MANUFACTURER'S PATIENT CARE NETWORK DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393396 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL CM2000 6385271 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention| H