BEUDAMED
    FDA Adverse Event Death Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 11798540 · Received May 10, 2021

    Report

    Report Number
    3004936110-2021-00334
    Event Type
    Death
    Date Received
    May 10, 2021
    Report Date
    August 10, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE ANALYSIS RESULTS ARE AVAILABLE BECAUSE NO DEVICE WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY IN AN ARTICLE TITLED AMBULATORY HEMODYNAMIC MONITORING REDUCES HEART FAILURE HOSPITALIZATIONS IN REAL-WORLD CLINICAL PRACTICE BY DESAI, A; BHIMRAJ, A; BHURMI, R ET AL., MA Y16 , 2017. "FOR THE ENTIRE COHORT, THERE WERE 1,899 ALL-CAUSE HOSPITALIZATIONS AND 1,020 HFHS IN THE 6 MONTHS BEFORE IMPLANTATION, COMPARED WITH 1,119 ALL-CAUSE HOSPITALIZATIONS, 381 HFHS, 17 VAD IMPLANTATIONS OR TRANSPLANTS, AND 139 DEATHS IN THE 6 MONTHS AFTER DEVICE IMPLANTATION. ... CLINICAL OUTCOMES FOR THE SUBSET OF PATIENTS WITH COMPLETE 12-MONTH DATA AVAILABLE FOR THE PERIOD BEFORE AND AFTER IMPLANTATION ARE SUMMARIZED IN TABLE 2. FOR THESE 480 SUBJECTS, THERE WERE 1,387 ALL-CAUSE HOSPITALIZATIONS AND 696 HFHS IN THE 12 MONTHS BEFORE IMPLANTATION, COMPARED WITH 859 ALL-CAUSE HOSPITALIZATIONS, 300 HFHS, 15 VAD IMPLANTATIONS OR TRANSPLANTS, AND 106 DEATHS AFTER DEVICE IMPLANTATION." THIS REPORT IS FOR THE REPORTED DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696298 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM2000

    Patients

    Seq Age Sex Outcome Treatment
    1 Death