BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS PATIENT ELECTRONIC SYSTEM

    MDR report key: 18889049 · Received March 12, 2024

    Report

    Report Number
    3004936110-2024-00384
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    February 12, 2024
    Report Date
    March 12, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CARDIOMEMS PATIENT ELECTRONIC SYSTEM WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION VERIFIED THE ANTENNA TX/ RX PORTIONS OF I3 STUFFED PCA OF THE PATIENT ELECTRONIC UNIT (PEU) WAS SEVERELY BURNT. UNIT FAILED SIGNAL ACQUISITION TEST STEP DISTANCE HOME AT 37MHZ AND FAILED REGISTER UNIT IN A SUBSEQUENT DIAGNOSTIC TEST WITH TEST I3 STUFFED PCA (600235017) AND TEST COMPACT FLASH CARD (CC-002002) (REFERENCE ATTACHED DIAGNOSTIC TEST RESULTS). DIAGNOSTIC TESTING WITH A TEST I3 FLEX ANTENNA ELEMENT (CS-001232) INCLUDED WITH THE TEST COMPONENTS ALREADY BEING USED RESULTED IN THE FAILURE OF THE ACCURACY/ NOISE HOME, DISTANCE HOME, AND REGISTER UNIT TEST STEPS. UNIT PASSED ALL TEST STEPS OF A DIAGNOSTIC TEST WITH AN ALTERNATE TEST I3 STUFFED PCA (600235017) AND THE RETURNED I3 FLEX ANTENNA ELEMENT (CS-001232) REINSTALLED. THE DEVICE HISTORY RECORD WAS REVIEWED 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

    BURNT ANTENNA TX/ RX PORTIONS OF I3 STUFFED PCA OF THE PATIENT ELECTRONIC UNIT (PEU) WERE DISCOVERED DURING EVALUATION OF THE DEVICE. 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
    720189 CARDIOMEMS PATIENT ELECTRONIC SYSTEM System, hemodynamic, implantable MOM ST. JUDE MEDICAL, INC. CM1100 8849950 05414734509800

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female