BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 20667661 · Received November 12, 2024

    Report

    Report Number
    3004936110-2024-01686
    Event Type
    Injury
    Date Received
    November 12, 2024
    Date of Event
    October 16, 2024
    Report Date
    December 17, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Removal / Correction Number
    FA-Q424-HF-1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    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, "PATIENT'S READINGS WERE NOT BEING QUESTIONED BUT WERE BELOW THE GOAL THRESHOLD. PATIENT WAS ASKED TO HOLD THEIR DIURETIC UNTIL READINGS ARE BACK IN RANGE... NO ADVERSE CONSEQUENCES. 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 33.95-MHZ AND 33.95-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 DEVICE IS INCLUDED IN THE FA-Q424-HF-1 HEART FAILURE CLOUD MIGRATION FSCA INITIATED ON 04OCT2024. IT WAS REPORTED THAT THE PATIENT RECEIVED MEDICATION CHANGES BASED ON CARDIOMEMS NUMBERS THAT WERE INACCURATE. THE PATIENT WAS DIRECTED TO CALL THEIR CLINIC IF THEY NOTICE ANY SYMPTOMS, AND THERE WERE NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513764 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000 8193704 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female