BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS PATIENT ELECTRONIC SYSTEM

    MDR report key: 12651584 · Received October 18, 2021

    Report

    Report Number
    3004936110-2021-00643
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    October 8, 2021
    Report Date
    February 28, 2022
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509800
    PMA / PMN Number
    P100045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PATIENT ELECTRONICS UNIT (PEU) CM1100, SN (B)(6) WAS RECEIVED FOR EVALUATION. THE STATE OF THE RETURNED DEVICE DID NOT ALLOW FOR COMPLETE TESTING AS THE UNIT WOULD NO LONGER BOOT, HOWEVER, IT WAS CONFIRMED THE UNIT DOES NOT CONTAIN A COMPACT FLASH CARD WITH THE INCORRECT SPEED SETTING. THE UNIT WAS REIMAGED WHICH CONFIRMED CORRUPTED SOFTWARE, UNRELATED TO ERROR 5. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE REPORTED ERROR 5 REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ELECTRONIC UNIT RECEIVED AN ERROR 5 MESSAGE, WHICH INDICATES AN ISSUE RELATED TO TEMPERATURE AND BAROMETRIC PRESSURE. A REPLACEMENT UNIT MAY RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546923 CARDIOMEMS PATIENT ELECTRONIC SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM1100 8118807 05414734509800

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male