BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 9340387 · Received November 19, 2019

    Report

    Report Number
    3004936110-2019-00595
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    October 25, 2019
    Report Date
    January 28, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE ANALYSIS RESULTS ARE AVAILABLE BECAUSE THE DEVICE REMAINS IMPLANTED. COMPLICATIONS RESULTING FROM INNATE PATIENT CONDITIONS THAT MANIFEST DURING IMPLANT, RECOVERY, OR USE OF THE PRODUCT MAY OCCUR IF CLINICAL CONSIDERATIONS ARE NOT FOLLOWED.. THE FOLLOWING EVENT REPORTED A PATIENT HEALTH OUTCOME OF CHEST PAIN. A RISK/BENEFIT ANALYSIS WAS PERFORMED PER THE CHAMPION CLINICAL TRIAL (TR-1002-149 VER. D) TO IDENTIFY POTENTIAL RISKS ASSOCIATED WITH USE OF THE CARDIOMEMS SYSTEM, AND THE RISK CONTROL MEASURES FOR THESE RISKS. THESE RISKS CAN BE CHARACTERISTIC OF PATIENTS WITH STAGE III/IV CONGESTIVE HEART FAILURE, OR FOR PATIENTS HAVING A RIGHT HEART CATHETERIZATION PROCEDURE, AND MAY BE UNRELATED TO THE CARDIOMEMS DEVICE OR DEVICE PROCEDURE(S).

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED CHEST PAIN FOLLOWING AN IMPLANT PROCEDURE. THE PATIENT WAS MONITORED POST- PROCEDURE AND ADMINISTERED NITROGLYCERIN. THE PATIENT WAS THEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135091 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000 6954008 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention