BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOMEMS PATIENT ELECTRONIC SYSTEM

    MDR report key: 17413215 · Received July 28, 2023

    Report

    Report Number
    3004936110-2023-00801
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    April 17, 2023
    Report Date
    May 9, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509800
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED. 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. IN ADDITION, A CORRECTIVE ACTION WAS INITIATED TO FURTHER INVESTIGATE.

    Description of Event or Problem · 0

    INFORMATION PROVIDED ON 18 JULY 2023 DURING A PHONE CONVERSATION WITH SITE NURSE, CLARIFIED: DESPITE THE PATIENT BEING TREATED FOR HIGH PES PRESSURES, THEY PRESENTED TO THE HOSPITAL INDEPENDENTLY TO BE EVALUATED FOR SHORTNESS OF BREATH. ALTHOUGH THE PATIENT WAS ADMITTED DUE TO THE HIGH PES READINGS, DURING THE HOSPITALIZATION, THE HS READINGS READ LOWER THAT THE HOME PES, SO THEY WERE NOT AGGRESSIVE WITH MEDICATION. BASED ON THIS INFORMATION, THERE WAS NO ALLEGED MALFUNCTION OR DETERIORATION IN THE CHARACTERISTICS OR PERFORMANCE OF THE CARDIOMEMS SENSOR, THAT RESULTED IN THE PATIENTS REPORTED SYMPTOMS.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED NON INVASIVELY (WITH ORAL MEDICATION) AND WAS RELEASED THE NEXT DAY. IT WAS REPORTED THE PATIENT HAS DISCONTINUED USE OF CARDIOMEMS.

    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 FOR SHORTNESS OF BREATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2318160 CARDIOMEMS PATIENT ELECTRONIC SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM1100 8185897 05414734509800

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention