BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 21679658 · Received March 24, 2025

    Report

    Report Number
    3004936110-2025-00456
    Event Type
    Injury
    Date Received
    March 24, 2025
    Date of Event
    March 10, 2025
    Report Date
    April 8, 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE ANALYSIS RESULTS ARE AVAILABLE BECAUSE THE DEVICE REMAINS IMPLANTED. THE SENSOR WAS REVIEWED AND FOUND OUTSIDE OF THE TOLERANCE FOR CM MEAN. THE CAUSE IS INCONCLUSIVE AT THIS TIME AND IS UNDER INVESTIGATION. PER THE EVENT DESCRIPTION, THE CHECK WAS PERFORMED USING DATA FROM A SWAN-GANZ CATHETER PLACED DURING A HOSPITALIZATION FOR HIGH PULMONARY ARTERY DIASTOLIC PRESSURE. THERE IS A CAPA ASSOCIATED WITH THE REPORTED EVENT; ANY NECESSARY ACTIONS WILL BE IMPLEMENTED BY THE CAPA. THIS AND SIMILAR EVENTS CONTINUE TO BE MONITORED AND TRENDED VIA QUALITY DATA REVIEW. 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 33.87 MHZ, 33.98 MHZ, AND 34.12 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    A RIGHT HEART CATHETERIZATION WAS PERFORMED PRIMARILY TO CONFIRM THE VALIDITY OF THE PRESSURE SENSOR READINGS DUE TO THE PATIENT HAVING SHORTNESS OF BREATH. THE SENSOR WAS RECALIBRATED AND THE MEAN WAS DECREASED BY 16 MMHG. READINGS WERE OBSERVED UNDER THE MANUFACTURER'S PATIENT CARE NETWORK DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739212 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ABBOTT MEDICAL. CM2000 7447510 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| R