BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 20248075 · Received September 18, 2024

    Report

    Report Number
    3004936110-2024-01196
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    August 26, 2024
    Report Date
    October 25, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS INVESTIGATED BUT CANNOT BE CONFIRMED AT THIS TIME AS THE ROOT CAUSE IS INCONCLUSIVE. PER THE INFORMATION RECEIVED THE SITE WILL CONTINUE TO MONITOR THE PATIENT TO DETERMINE WHAT THE PATIENT'S GOAL PRESSURES SHOULD BE. 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 36.40 MHZ AND 36.67 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO SYNCOPE, HYPOTENSION AND AN ACUTE KIDNEY INJURY. IT WAS REPORTED THAT THE SITE DETERMINED THE PATIENT'S CARDIOMEMS GOAL PRESSURE WAS WAS SET TOO LOW. IT IS BELIEVED THE PATIENT TOOK TOO MUCH DIURETIC. THE PATIENT WAS TREATED WITH FLUIDS AND HAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360356 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000 6503220 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Required Intervention| H