BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 22319399 · Received June 24, 2025

    Report

    Report Number
    3004936110-2025-01151
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    May 27, 2025
    Report Date
    July 23, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    THE REPORTED ISSUE WAS INVESTIGATED BUT CANNOT BE CONFIRMED AT THIS TIME AS THE ROOT CAUSE IS INCONCLUSIVE. PER THE EVENT DESCRIPTION, "THE PATIENT HAS BEEN DISCHARGED AND THEY ARE CONTINUING TO TAKE THEIR READINGS FROM HOME. THE PATIENT'S GOALS HAVE BEEN ADJUSTED AND THE SITE IS NO LONGER QUESTIONING THE ACCURACY OF THE CARDIOMEMS SENSOR." 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 33.49 MHZ, 33.45 MHZ, 33.68 MHZ, AND 33.48 MHZ DURING THE REVIEW OF THE APPLICABLE READING(S). 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

    THE PHYSICIAN STATED THAT THEY BELIEVE THEY OVER-TREATED THE PATIENT BASED ON NUMBERS PROVIDED BY THE CARDIOMEMS SENSOR. THE PATIENT WAS HOSPITALIZED. AWAITING UPDATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2088994 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ABBOTT MEDICAL CM2000 10600283 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Hospitalization