BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 1162812 · Received September 16, 2008

    Report

    Report Number
    2916596-2008-00131
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 17, 2008
    Report Date
    August 17, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH BIVENTRICULAR SUPPORT. IT WAS REPORTED BY THE NURSE EDUCATOR THAT THE PVAD RVAD WAS EXCHANGED DUE TO THE PUMP NEARLY BEING CLOTTED OFF. 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 47 YR Required Intervention