BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 1250365 · Received December 3, 2008

    Report

    Report Number
    2916596-2008-00173
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 6, 2008
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP EXCHANGE WAS PERFORMED AS PLANNED. THE PT REMAINS STABLE. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH BIVENTRICULAR SUPPORT. IT WAS REPORTED BY THE VAD COORDINATOR THAT DURING IMPLANT, WHEN THE DE-AIRING PROCESS AND HAND PUMPING OF THE RVAD RVAD WAS TAKING PLACE, THERE WAS RESISTANCE AND THE INTERNAL THORALON SAC DID NOT COLLAPSE. THE PUMP WAS EXCHANGED AND WAS DE-AIRED AND HAND PUMPED 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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention