BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS PATIENT ELECTRONIC SYSTEM

    MDR report key: 18855345 · Received March 7, 2024

    Report

    Report Number
    3004936110-2024-00351
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Date of Event
    March 5, 2024
    Report Date
    April 8, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509800
    PMA / PMN Number
    P100045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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

    ONE CARDIOMEMS PATIENT ELECTRONIC SYSTEM WAS RECEIVED FOR EVALUATION.. EXTERNAL AND INTERNAL VISUAL INSPECTIONS OF UNIT REVEALED EXPOSED AND DETACHED WIRING FROM THE HANDHELD POWER CABLE. DURING THE INVESTIGATION, VISUAL INSPECTION REVEALED THAT THE POWER EXTENSION CONNECTOR WAS SEATED IN THE CONNECTOR COVER. IN ADDITION, NO POWER CLIP WAS ATTACHED AND/OR RETURNED. ALL STANDARD ACCESSORIES WERE USED INCLUDING HANDHELD CASING, LCD SCREEN, HANDHELD PCB BOARD, HANDHELD POWER CABLE, AND GOLDEN HANDHELD MEMBRANE BUTTON. NO SOFTWARE MALFUNCTIONS, ERRORS, WARNINGS, OR ANOMALIES WERE OBSERVED DURING UNIT BOOT OR DURING HANDHELD TOUCH SCREEN COMMANDS. THE FIELD REPORTED EVENT OF HANDHELD DEVICE CORD BEING SEVERED AND DETACHED FROM THE PATIENT ELECTRONIC UNIT WAS CONFIRMED. A REVIEW OF THE DHR WAS PERFORMED FOR BATCH #9043533 AND RULED OUT THE POSSIBILITY OF A MANUFACTURING RELATED ISSUE CAUSING OR CONTRIBUTING TO THE REPORTED COMPLAINT ISSUE, AS NO NON-CONFORMANCE RELATED TO THE REPORTED ISSUE WAS FOUND IN THE BATCH RECORDS REVIEWED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED EXPOSED WIRES ON THE HANDHELD DEVICE CABLE. THE PATIENT ELECTRONIC UNIT WAS REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908326 CARDIOMEMS PATIENT ELECTRONIC SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM1100 9043533 05414734509800

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male