BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 21448254 · Received February 24, 2025

    Report

    Report Number
    3004936110-2025-00375
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    February 19, 2025
    Report Date
    May 30, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE SENSOR WAS REVIEWED AND FOUND OUTSIDE OF THE TOLERANCE FOR CM MEAN USING ECHO. THE CAUSE IS INCONCLUSIVE AT THIS TIME AND IS UNDER INVESTIGATION. PER THE EVENT DESCRIPTION, "THE BASELINE CODE HAS NOW BEEN CHANGED IN MERLIN. MERLIN.NET BACKEND SHOWS THAT THE BASELINE WAS INCREASED BY 10 MMHG ON (B)(6) 2025." 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 35.29-MHZ, 35.11-MHZ, AND 35.26-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. A LOT REVIEW WAS PERFORMED VIA COMPLAINT HANDLING SYSTEM (EPIQ) USING A SEARCH ON THE BATCH NUMBER. CONCLUSIVELY, THERE ARE NO ADDITIONAL COMPLAINT(S) RELATED TO THE ASSOCIATED BATCH, AND THE REPORTED ISSUE.

    Description of Event or Problem · 0

    THE PRIMARY REASON FOR THE ECHO WAS TO CHECK THE ACCURACY OF THE CM SENSOR. THE SITE DID AN ECHO ON (B)(6) 2025.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN ECHOCARDIOGRAM TO CHECK THE ACCURACY OF THE SENSOR. A BACKEND RECALIBRATION WAS DONE BASED ON THE RESULTS OF THE ECHOCARDIOGRAM TO UPDATE THE PATIENT'S BASELINE CODES. MERLIN.NET BACKEND SHOWS THAT THE BASELINE WAS INCREASED BY 10 MMHG ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526747 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ABBOTT MEDICAL CM2000 8380658 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention