BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    MICRA

    MDR report key: 13844688 · Received March 22, 2022

    Report

    Report Number
    13844688
    Event Type
    No answer provided
    Date Received
    March 22, 2022
    Date of Event
    February 7, 2022
    Report Date
    March 11, 2022
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    PNJ
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE MICRA PACEMAKER DELIVERY SYSTEM WAS PREPPED AND INSERTED THROUGH THE DELIVERY SHEATH TO THE LEVEL OF THE RIGHT ATRIUM. THE SYSTEM WAS ADVANCED TO THE REGION OF THE SUPERIOR INTRAVENTRICULAR SEPTUM OF THE RIGHT VENTRICLE. UPON ADVANCING THE DELIVERY SYSTEM ACROSS THE TRICUSPID VALVE INTO THE RIGHT VENTRICLE IT WAS SUDDENLY NOTED THAT THE PATIENT HAD A SIGNIFICANT DROP IN HIS BLOOD PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641318 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown