BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 22993514 · Received September 8, 2025

    Report

    Report Number
    3004936110-2025-01692
    Event Type
    Malfunction
    Date Received
    September 8, 2025
    Date of Event
    August 26, 2025
    Report Date
    October 7, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MOM
    UDI-DI
    05414734509237
    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

    THE INVESTIGATION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    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 FOR REASONS UNRELATED TO THE ACCURACY OF THE CARDIOMEMS SENSOR. THE SENSOR WAS RECALIBRATED AND THE MEAN WAS INCREASED BY 18.2 MMHG. READINGS WERE OBSERVED UNDER THE MANUFACTURER'S PATIENT CARE NETWORK DATABASE. THE FOLLOWING WERE PREVIOUS REPORTS SUBMITTED FOR THIS PATIENT DUE TO A RECURRING RHC FOR ASSESSMENT OF LVAD PLACEMENT. MDV-(B)(4), MDV-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2466232 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ABBOTT MEDICAL CM2000 8536293 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Required Intervention