BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 17604596 · Received August 23, 2023

    Report

    Report Number
    3004936110-2023-00867
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    August 8, 2023
    Report Date
    August 23, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Removal / Correction Number
    Z-1223-2023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS INVESTIGATED BUT CANNOT BE CONCLUSIVELY CONFIRMED AT THIS TIME AS THE ROOT CAUSE IS UNKNOWN. IT IS SUSPECTED THAT THE REPORTED ISSUE COULD BE RELATED TO AN OUT OF RANGE SENSOR OPERATION. THIS REPORTED EVENT WAS INVESTIGATED FOR POSSIBLE INACCURATE READING. BASED ON THE INFORMATION GIVEN AND BACKEND LOG ANALYSIS, IT WAS CONFIRMED THAT THE DEVICE WAS OPERATING OUTSIDE THE EXPECTED FREQUENCY RANGE OF 30-37.5 MHZ. THE SENSOR WAS OPERATING AT 38.3 AND 34.0 MHZ DURING THE REVIEW OF THE APPLICABLE READING(S). THE INACCURACY DETERMINED BY THE TECHNICAL HEART FAILURE TEAM WAS OUTSIDE THE PREDICTED RANGE FROM THE IFU. THE DEVICE IS INCLUDED IN THE 3004936110-01/24/23-002C SENSOR OUT OF FREQUENCY ADVISORY NOTICE ISSUED BY ABBOTT ON 07 FEB 2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SENSOR ACCURACY WAS QUESTIONED WHILE THE PATIENT WAS ON VACATION IN ECUADOR. THIS REPORTED EVENT WAS INVESTIGATED FOR POSSIBLE INACCURATE READING. BASED ON THE INFORMATION GIVEN AND BACKEND LOG ANALYSIS, IT WAS CONFIRMED THAT THE DEVICE WAS OPERATING OUTSIDE THE EXPECTED FREQUENCY RANGE OF 30-37.5 MHZ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725170 HF SENSOR DELIVERY SYSTEM System, hemodynamic, implantable MOM ST. JUDE MEDICAL, INC. CM2000 7562882 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown