BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS PATIENT ELECTRONIC SYSTEM

    MDR report key: 21566418 · Received March 10, 2025

    Report

    Report Number
    3004936110-2025-00446
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    March 7, 2025
    Report Date
    April 10, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MOM
    UDI-DI
    05414734509800
    PMA / PMN Number
    P100045
    Removal / Correction Number
    FA-Q323-HF-4
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ONE I3 UNIT MODEL CM1100 WITH MAIN UNIT SERIAL #(B)(6) AND ONE I3 ACCESSORY SET WAS RETURNED EXCLUDING POWER CORD AND POWER SUPPLY. EXTERNAL AND INTERNAL VISUAL INSPECTIONS OF UNIT REVEALED EXPOSED WIRES OF RIGHT ANG EXT, 2.5ID/5.5OD 16AWG. IT IS UNDETERMINED IF THERE WERE ANY ADDITIONAL FINDINGS ON THE POWER SUPPLY AND POWER CORD SINCE IT WAS NOT RETURNED WITH THE UNIT. CUSTOMER REPORTED UNIT REVEALED EXPOSED WIRES ON POWER CONNECTOR CORD. - CONFIRMED.

    Additional Manufacturer Narrative · 0

    FA-Q323-HF-4 CARDIOMEMS PES RIGHT ANGLE POWER EXTENSION CABLE FAILURE NOTICE ISSUED BY ABBOTT ON 04 OCT 2023. THE INVESTIGATION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 0

    THE PATIENT REPORTED EXPOSED WIRES OF THE POWER EXTENSION CABLE. THE PATIENT ELECTRONICS DEVICE WAS REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198674 CARDIOMEMS PATIENT ELECTRONIC SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ABBOTT MEDICAL CM1100 10056590 05414734509800

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male