BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2130648 · Received June 14, 2011

    Report

    Report Number
    2916596-2011-00240
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT PUMP STOPPAGES WERE NOTICED ON THE SYSTEM CONTROLLER LOG FILE. THE SYSTEM CONTROLLER WAS EXCHANGED FOR ANOTHER SYSTEM CONTROLLER AND NO FURTHER PROBLEMS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 95815

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention