BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 3950516 · Received July 11, 2014

    Report

    Report Number
    2916596-2014-01167
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT CONTINUES ON BI-VAD SUPPORT WITH NO FURTHER ISSUE REPORTED. 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 A BI-VENTRICULAR ASSIST DEVICE (BI-VAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT SUFFERED HEMORRHAGIC STROKE AND NOW HAS "LOCKED IN" SYNDROME. THE PATIENT IS BEING MONITORED FOR POTENTIAL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407952 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM DSQ: VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 14086-2550-000 109848

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention RVAD 13209