BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRICULAR ASSIST DEVICE (IVAD)

    MDR report key: 1910437 · Received November 18, 2010

    Report

    Report Number
    2916596-2010-00308
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 13, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFO 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 PT WAS IMPLANTED WITH AN IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE IVAD WAS NOT ABLE TO GET AN EJECT LIGHT ON THE SIGNAL PROCESSOR LEAD WHILE ON THE DUAL DRIVE CONSOLE. THE PT WAS THEN PLACED ON A TLC-II AND RVAD OCCLUSION ALARMS OCCURRED. THE TLC-II DRIVER WAS THEN REPLACED, HOWEVER, THE ALARMS PERSISTED SO PT WAS AGAIN PLACED BACK ON THE DDC, AND TAKEN TO THE OPERATING ROOM WHERE A PUMP EXCHANGE TOOK PLACE FROM ONE IVAD PUMP TO ANOTHER IVAD PUMP. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRICULAR ASSIST DEVICE (IVAD) IMPLANTABLE VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 10012-2555-001 63783

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention