BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 14989530 · Received July 12, 2022

    Report

    Report Number
    3004936110-2022-00383
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    June 28, 2022
    Report Date
    July 7, 2025
    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
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H2, H3, H6. 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

    THE SENSOR TRANSMITTED A DAMPENED WAVEFORM READING. THE PHYSICIAN IS CURRENTLY MONITORING THE PATIENT AND THE SENSOR READINGS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A RIGHT HEART CATHETERIZATION WAS PERFORMED TO CONFIRM THE VALIDITY OF THE PRESSURE SENSOR READINGS. THE WAVEFORMS AND DATA DID NOT MATCH THE DATA OBTAINED FROM THE RECALIBRATION. DUE TO THE PREVIOUSLY REPORTED DAMPENING, THE SENSOR WAS NOT RECALIBRATED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THROUGH A LITERATURE REVIEW REPORTING THAT DURING THIS RIGHT HEART CATHETERIZATION THEY FOUND THAT THE SENSOR WAS COMPLETELY ENDOTHELIALIZED. THE SECOND SENSOR IMPLANT IS REPORTED IN MDR-2025-29147.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638793 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000 7054205 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention