BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 21267789 · Received January 29, 2025

    Report

    Report Number
    3004936110-2025-00158
    Event Type
    Injury
    Date Received
    January 29, 2025
    Date of Event
    January 28, 2025
    Report Date
    February 13, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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

    A REVIEW OF THE INFORMATION PROVIDED WAS PERFORMED, AND THE SENSOR WAS WITHIN THE TOLERANCE FOR CM MEAN; THEREFORE, THE REPORTED EVENT IS UNCONFIRMED. 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 34.05 MHZ AND 33.81 MHZ DURING THE REVIEW OF THE APPLICABLE READING(S). THERE IS NO CAPA ASSOCIATED WITH THE REPORTED EVENT, AS THERE IS NO NEW HARM OR RISK IDENTIFIED FOR THE PATIENT OR USER. THIS AND SIMILAR EVENTS ARE MONITORED AND TRENDED VIA QUALITY DATA REVIEW. A CAPA WILL IMPLEMENT NECESSARY ACTIONS IF REQUIRED. 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 THREE ADDITIONAL COMPLAINT(S) RELATED TO THE ASSOCIATED BATCH, AND THE REPORTED ISSUE.

    Description of Event or Problem · 0

    A RIGHT HEART CATHETERIZATION WAS PERFORMED TO CONFIRM THE VALIDITY OF THE PRESSURE SENSOR READINGS. THE SENSOR WAS NOT RECALIBRATED. READINGS WERE OBSERVED UNDER THE MANUFACTURER'S PATIENT CARE NETWORK DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830997 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ABBOTT MEDICAL CM2000 8915574 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention