BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOMEMS PATIENT ELECTRONIC SYSTEM

    MDR report key: 17388792 · Received July 25, 2023

    Report

    Report Number
    3004936110-2023-00771
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    June 18, 2023
    Report Date
    November 17, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509800
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF INACCURATE READINGS WAS RESOLVED PER THE CLINIC ON 13OCT2023. NO ADDITIONAL INVESTIGATION WAS REQUESTED, AND THEY CONFIRMED READINGS WERE SATISFACTORY. NO READINGS WITH THE HOSPITAL ELECTRONICS SYSTEM OR OTHER INTERROGATOR WERE TAKEN ON THE COMPLAINT DATE, SO NO BASIS FOR COMPARISON WAS ESTABLISHED. IF THE ISSUE PERSISTS, A NEW COMPLAINT WILL BE GENERATED AND THE EVENT WILL BE INVESTIGATED. 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

    THE PATIENT'S HEALTHCARE PROVIDER REPORTED THAT THEY BELIEVE THE CARDIOMEMS PATIENT ELECTRONICS UNIT (PEU) PROVIDED INACCURATE READINGS WHICH LEAD TO OVER TREATMENT OF THE PATIENT. THE SITE TREATED THE PATIENT ACCORDING TO THE PEU WHICH REPORTEDLY SHOWED HIGH PRESSURES. THE PATIENT WAS HOSPITALIZED AND FOUND TO HAVE HYPERKALEMIA AND HYPOVOLEMIA. THE PATIENT WAS DISCHARGED FOUR DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946737 CARDIOMEMS PATIENT ELECTRONIC SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM1100 8748842 05414734509800

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention| H