BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 1130963 · Received August 21, 2008

    Report

    Report Number
    2916596-2008-00113
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 24, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP EXCHANGE WAS PERFORMED AS PLANNED. THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH LEFT VENTRICULAR ASSIST SUPPORT. IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PVAD LVAD WAS EXCHANGED DUE TO INCREASED HEMOLYSIS PARAMETERS. THE PUMP WAS EXCHANGED WITHOUT ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention