BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 23405934 · Received October 28, 2025

    Report

    Report Number
    3004936110-2025-06325
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    October 17, 2025
    Report Date
    January 16, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    IT WAS REPORTED THAT THE PATIENT HAD AN RHC TO CHECK THE ACCURACY OF THE SENSOR AND ASSESS THE CAUSE OF THE DAMPENED WAVEFORMS (REPORTED IN MDV-2025-29600). THE SENSOR WAS NOT RECALIBRATED AND THE PRESSURES DID NOT MATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029243 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ABBOTT MEDICAL CM2000 5274440 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention