BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 18855160 · Received March 7, 2024

    Report

    Report Number
    3004936110-2024-00357
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Date of Event
    February 26, 2024
    Report Date
    September 17, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC. - CARDIOMEMS
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE ANALYSIS RESULTS ARE AVAILABLE BECAUSE THE DEVICE REMAINS IMPLANTED. A REVIEW OF THE INFORMATION PROVIDED WAS PERFORMED, AND THE SENSOR WAS WITHIN THE TOLERANCE FOR CM MEAN COMPARED TO MEASUREMENTS ACQUIRED DURING AN ECHOCARDIOGRAM. BASED ON A BACKEND LOG ANALYSIS, IT WAS CONFIRMED THAT THE SENSOR WAS OPERATING WITHIN THE EXPECTED FREQUENCY RANGE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED 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.

    Description of Event or Problem · 0

    A RIGHT HEART CATHETERIZATION WAS PERFORMED TO CONFIRM THE VALIDITY OF THE PRESSURE SENSOR READINGS. THE SENSOR WAS RECALIBRATED AND THE MEAN WAS DECREASED BY 6.5 MMHG. READINGS WERE OBSERVED UNDER THE MANUFACTURER'S PATIENT CARE NETWORK DATABASE.¿

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT A RIGHT HEART CATHETERIZATION WAS PERFORMED TO CONFIRM THE VALIDITY OF THE PRESSURE SENSOR READINGS. ADDITIONAL INFORMATION PROVIDED CONFIRMED THAT AN ECHOCARDIOGRAM WAS PERFORMED RATHER THAN A RIGHT HEART CATHETERIZATION. THE REPORTED SENSOR RECALIBRATION WITH A MEAN DECREASE BY 6.5 MMHG IS ACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171301 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. - CARDIOMEMS CM2000 8791121 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention