BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOMEMS PATIENT ELECTRONIC SYSTEM

    MDR report key: 19018384 · Received April 2, 2024

    Report

    Report Number
    3004936110-2024-00466
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    March 13, 2024
    Report Date
    June 28, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509800
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE ANALYSIS RESULTS ARE AVAILABLE BECAUSE THE DEVICE WAS NOT RETURNED. THIS REPORTED EVENT WAS INVESTIGATED FOR POSSIBLE INACCURATE READING. BASED ON A BACKEND LOG ANALYSIS, IT WAS CONFIRMED THAT THE SENSOR WAS OPERATING WITHIN THE EXPECTED FREQUENCY RANGE OF 30-37.5-MHZ. THE SENSOR WAS OPERATING AT 33.81-MHZ AND 33.06-MHZ DURING THE REVIEW OF THE APPLICABLE READING(S). 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.

    Additional Manufacturer Narrative · 0

    IT WAS CONFIRMED THAT THE SITE WAS QUESTIONING THE ACCURACY OF THE CARDIOMEMS PES READINGS, NOT THE SENSOR. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR HYPOTENSION AND SYNCOPE DUE TO OVER DIURESIS.

    Description of Event or Problem · 0

    IT WAS CONFIRMED THAT THE SITE WAS QUESTIONING THE ACCURACY OF THE CARDIOMEMS PES READINGS. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR HYPOTENSION AND SYNCOPE DUE TO OVER DIURESIS. THE REPORTED EVENT THAT THE PES HAD SOME EMI READINGS AND HAD ITS ACCURACY QUESTIONED WAS RESOLVED ON (B)(6) 2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SITE WAS QUESTIONING THE ACCURACY OF THE CARDIOMEMS SENSOR READINGS. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR HYPOTENSION AND SYNCOPE DUE TO OVER DIURESIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SITE WAS QUESTIONING THE ACCURACY OF THE CARDIOMEMS PES READINGS. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR HYPOTENSION AND SYNCOPE DUE TO OVER DIURESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362568 CARDIOMEMS PATIENT ELECTRONIC SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM1100 8946939 05414734509800

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Hospitalization| R