BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 25112817 · Received May 7, 2026

    Report

    Report Number
    3004936110-2026-00718
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 7, 2026
    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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOMEMS SENSOR MIGRATED FROM ITS ORIGINAL IMPLANT LOCATION IN THE LEFT PULMONARY ARTERY TO THE RIGHT PULMONARY ARTERY. THE PATIENT WAS ABLE TO OBTAIN A READING USING A HOSPITAL MONITORING SYSTEM ON (B)(6) 2026; HOWEVER, THEY HAVE BEEN UNABLE TO OBTAIN A READING WITH THEIR PATIENT ELECTRONICS DEVICE SINCE THE MIGRATION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572393 HF SENSOR DELIVERY SYSTEM System, hemodynamic, implantable MOM ABBOTT MEDICAL CM2000 10906478 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1