BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 3122092 · Received May 16, 2013

    Report

    Report Number
    2916596-2013-00596
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    December 21, 2012
    Report Date
    April 17, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PVAD RVAD REMAINS IN USE SUPPORTING THE PATIENT. (REFERENCE MFR. REPORT # 0002916596-2013-00597 FOR PVAD LVAD). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH BIVENTRICULAR SUPPORT (PVAD LVAD AND PVAD RVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS ADMITTED FOR HEMOLYSIS. THE PATIENT WAS GIVEN TWO UNITS OF BLOOD. THE VAD COORDINATOR ALSO MENTIONED THAT THE PATIENT HAS SMALL VENTRICLES AND THAT THE HEMOLYSIS COULD BE A RESULT OF THE CANNULAE PLACEMENT DUE TO SMALL VENTRICLES. THE PATIENT IS BEING MONITORED DURING REGULARLY SCHEDULED CLINIC VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217410 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM DSQ: VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 14086-2550-000 119296

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention