BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORATEC

    MDR report key: 1725549 · Received June 11, 2010

    Report

    Report Number
    1725549
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 10, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2010, THE PT HAD A REPORTED LOSS OF CONSCIOUSNESS AND SHORTLY THEREAFTER THE PARAMEDICS ARRIVED AND TRANSPORTED HER TO THE MAYO CLINIC HOSPITAL EMERGENCY DEPARTMENT. THE DEVICE HAD A FRACTURE AT THE JUNCTION POINT OF THE DRIVELINE TO THE DEVICE HOUSING. IMPRESSION: FAILURE OF PT'S EXTERNAL LVAD DEVICE AND SUBSEQUENT EMERGENCY SWITCH OUT/REPLACEMENT OF LEFT VENTRICULAR (PERIPHERAL) ASSIST DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC LVAD BLOOD PUMP DSQ THORATEC CORP. 14086-2550-000 79570

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Death