BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 21394726 · Received February 18, 2025

    Report

    Report Number
    3004936110-2025-00206
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    November 18, 2024
    Report Date
    April 18, 2025
    Manufacturer
    ABBOTT MEDICAL.
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF SIGNAL ACQUISITION DIFFICULTY WAS CONFIRMED. ROTATION OF THE SENSOR WAS CONFIRMED VIA CHEST X-RAY. ADDITIONAL TROUBLESHOOTING OF THE PATIENT SIGNAL ACQUISITION WAS NOT POSSIBLE AS THE PATIENT DIED FOR REASONS UNRELATED TO THE CARDIOMEMS DEVICE OR IMPLANT PROCEDURE PER THE HEALTHCARE PROVIDER. 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 OPERATED AT 34.48 MHZ. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S SENSOR IS ROTATED AND THEY HAVE BEEN UNABLE TO OBTAIN A READING FROM IT WITH THE PATIENT ELECTRONICS DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. CONTINUED TROUBLESHOOTING IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623922 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ABBOTT MEDICAL. CM2000 10253045 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male