BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 17033178 · Received May 31, 2023

    Report

    Report Number
    3004936110-2023-00562
    Event Type
    Injury
    Date Received
    May 31, 2023
    Date of Event
    May 11, 2023
    Report Date
    June 22, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509237
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE ANALYSIS RESULTS ARE AVAILABLE BECAUSE THE DEVICE REMAINS IMPLANTED. A REVIEW OF THE DHR WAS PERFORMED AND RULED OUT THE POSSIBILITY OF A MANUFACTURING RELATED ISSUE CAUSING OR CONTRIBUTING TO THE REPORTED COMPLAINT ISSUE. PER THE RISK/BENEFIT ANALYSIS (TR-1002-149 VER. F), THESE RISKS CAN BE CHARACTERISTIC FOR PATIENTS HAVING A RIGHT HEART CATHETERIZATION PROCEDURE. HEMOPTYSIS AND RESPIRATORY DISTRESS HAVE BEEN IDENTIFIED AS A KNOWN POTENTIAL ADVERSE EVENT THAT MAY OCCUR AS A RESULT OF TRAUMA TO THE PULMONARY ARTERY DURING CARDIOMEMS SENSOR IMPLANT.

    Description of Event or Problem · 0

    DURING CARDIOMEMS IMPLANT PROCEDURE THE PATIENT EXPERIENCED HEMOPTYSIS. THE EVENT RESOLVED WITHOUT ANY INTERVENTION. A CT SCAN CONFIRMED A PERFORATION IN THE LEFT LOWER LOBE OF THE LEFT LUNG. THE PHYSICIAN REPORTS THE CAUSE OF THE HEMOPTYSIS TO BE THE NON-ABBOTT GUIDEWIRE. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION AND DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682845 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000 8651271 05414734509237

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Unknown Hospitalization