BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 18582290 · Received January 25, 2024

    Report

    Report Number
    3004936110-2024-00148
    Event Type
    Injury
    Date Received
    January 25, 2024
    Report Date
    March 27, 2024
    Product Code
    MOM
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS INVESTIGATED BUT CANNOT BE CONFIRMED AT THIS TIME AS THE ROOT CAUSE WAS INCONCLUSIVE. THERE IS NO CAPA ASSOCIATED WITH THE REPORTED EVENT, AS THERE IS NO NEW HARM OR RISK IDENTIFIED FOR THE PATIENT OR USER. THIS AND SIMILAR EVENTS ARE MONITORED AND TRENDED VIA QUALITY DATA REVIEW. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT/BATCH/SERIAL NUMBER OF THE DEVICE WERE UNAVAILABLE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF THE AMERICAN HEART ASSOCIATION IN AN ARTICLE TITLED "EARLY EXPERIENCE AND LESSONS LEARNED USING IMPLANTED HEMODYNAMIC MONITORING IN PATIENTS WITH FONTAN CIRCULATION" BY WILLIAM H. MARSHALL V; SAURABH RAJPAL, MD, MAY LING MAH, MD; AIMEE K. ARMSTRONG, MD; ARASH SALAVITABAR, MD; JENNE HICKEY, FNP-BC; RACHEL METZGER, A-GNP; TRACEY SISK, RN AND CURT J. DANIELS, MD. PATIENT WITH PRIOR ARTERIOVENOUS MALFORMATIONS IN THE RIGHT LUNG RESULTING FUNCTIONALLY IN A SINGLE LEFT LUNG, DEVELOPED A PULMONARY EMBOLISM IN THE LEFT LOWER MEDIAL BRANCH OF THE PULMONARY ARTERY, ADJACENT TO THE DISTAL END OF THE [CARDIOMEMS SENSOR] (54 MONTHS AFTER [SENSOR] PLACEMENT), SUCH THAT IT WAS POSSIBLY DEVICE RELATED. [THE PATIENT] WAS OFF ANTICOAGULATION DUE TO UTERINE BLEEDING, LEADING TO A HYSTERECTOMY ONE WEEK BEFORE THE PULMONARY EMBOLISM WAS DIAGNOSED. THE CLOT BURDEN IMPROVED WITH CATHETER-DIRECTED THROMBOLYTIC THERAPY AND RESUMPTION OF SYSTEMIC ANTICOAGULATION, WITH NO FURTHER THROMBOTIC EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2135263 HF SENSOR DELIVERY SYSTEM SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM CM2000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention