BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOMEMS PATIENT ELECTRONIC SYSTEM

    MDR report key: 15854722 · Received November 23, 2022

    Report

    Report Number
    3004936110-2022-00664
    Event Type
    Injury
    Date Received
    November 23, 2022
    Date of Event
    October 27, 2022
    Report Date
    November 23, 2022
    Manufacturer
    ST. JUDE MEDICAL, INC. - CARDIOMEMS
    Product Code
    MOM
    UDI-DI
    05414734509800
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CARDIOMEMS PATIENT ELECTRONIC SYSTEM WAS RECEIVED FOR EVALUATION. INITIAL ATTEMPTS TO TRANSMIT DATA VIA GSM WERE UNSUCCESSFUL. AFTER INSPECTION OF THE HANDHELD OPTIONS, IT WAS OBSERVED THAT THE GSM SETTING WAS DISABLED. PATIENT DATA BACKUP WAS PERFORMED SUCCESSFULLY AFTER ENABLING GSM. LAND LINE TRANSMISSION WAS ALSO TESTED AND REVIEW OF SETTINGS CONFIRMED THE TELEPHONE DIAL PREFIX WAS SET TO '9' ON INITIAL BOOT UP. AFTER CHANGING THE PREFIX TO 'NONE', PATIENT DATA BACKUP WAS PERFORMED SUCCESSFULLY VIA LAND LINE. THE WIFI ADAPTOR WAS NOT RETURNED WITH THE UNIT THEREFORE THE WIFI TRANSMISSION ISSUE COULD NOT BE CONFIRMED. THE REPORTED EVENT WAS CONFIRMED AND THE ROOT CAUSE WAS DETERMINED TO BE INCORRECT LAND LINE PREFIX AND GSM SETTING DISABLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR HEART FAILURE. THE PATIENT HAD BEEN EXPERIENCING COMMUNICATION ISSUES WITH THE PATIENT ELECTRONICS UNIT. THE UNIT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413705 CARDIOMEMS PATIENT ELECTRONIC SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. - CARDIOMEMS CM1100 8538331 05414734509800

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization