BEUDAMED
    FDA Adverse Event Death Summary report: N

    URCHIN HEART POSITIONER

    MDR report key: 457664 · Received May 1, 2003

    Report

    Report Number
    2135394-2003-00001
    Event Type
    Death
    Date Received
    May 1, 2003
    Date of Event
    April 3, 2003
    Manufacturer
    MEDTRONIC CARDIAC SURGERY TECHNOLOGIES
    Product Code
    DWS
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THAT DURING HEART POSITIONING TO EXPOSE THE CIRCUMFLEX SYSTEM, THE APEX OF THE HEART RUPTURED. EMERGENCY REPAIR WAS PERFORMED. THE PT WENT INTO MULTI-SYSTEM FAILURE SECONDARY TO LOW-OUTPUT SYNDROME. PT LATER EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URCHIN HEART POSITIONER * DWS MEDTRONIC CARDIAC SURGERY TECHNOLOGIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1