BEUDAMED
    FDA Adverse Event Death Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 9367183 · Received November 24, 2019

    Report

    Report Number
    3004936110-2019-00641
    Event Type
    Death
    Date Received
    November 24, 2019
    Report Date
    November 24, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC. - CARDIOMEMS
    Product Code
    MOM
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ANALYSIS RESULTS ARE AVAILABLE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE FOLLOWING EVENT COULD NOT BE CONCLUSIVELY DETERMINED TO BE IN RELATION TO THE CARDIOMEMS DEVICE OR PROCEDURE.

    Description of Event or Problem · 1

    OTHER RELATED MFR REPORT NUMBERS ARE: 3004936110-2019-00444, 3004936110-2019-00446, 3004936110-2019-00601, 3004936110-2019-00602, 3004936110-2019-00611, 3004936110-2019-00637, 3004936110-2019-00638, 3004936110-2019-00639, 3004936110-2019-00640, 3004936110-2019-00642, 3004936110-2019-00643. ONE CASE OF PATIENT DEATH WITHIN 30 DAYS OF IMPLANT REPORTED IN ASSOCIATION WITH A CMEMS SENSOR FROM THE LITERATURE ARTICLE BELOW. MEASURES OF PROCEDURE SAFETY WERE IN-HOSPITAL AND 30-DAY MORTALITY AND IMPLANT COMPLICATIONS, INCLUDING ACCESS SITE HEMATOMA, PNEUMOTHORAX, PA INJURY/HEMOPTYSIS, AND INABILITY TO DEPLOY DEVICE....COMPLICATIONS, INCLUDING ONE CASE OF HEMATOMA AND 4 CASES OF MILD HEMOPTYSIS, AND 30-DAY MORTALITY (2%¿3%) DID NOT DIFFER BETWEEN GROUPS." THE PATIENT DIED POD (POST OPERATIVE DAY) 16 DUE TO CHOLECYSTITIS AND SEPSIS. FURTHER INFORMATION WAS REQUESTED AND NOT AVAILABLE PER THE RESEARCH TEAM INVOLVED WITH SAID ARTICLE. INTERNAL JUGULAR VEIN AS ALTERNATIVE ACCESS FOR IMPLANTATION OF A WIRELESS PULMONARY ARTERY PRESSURE SENSOR. PUBLICATION INFO: CIRCULATION. HEART FAILURE 12.8: E006060. NLM (MEDLINE). (AUG 1, 2019).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161761 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. - CARDIOMEMS CM2000

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death