BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2190589 · Received July 25, 2011

    Report

    Report Number
    2916596-2011-00317
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 23, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY EXCHANGED WITH ANOTHER LVAD AND THE PT REMAINS ONGOING ON LVAD SUPPORT WITHOUT ANY FURTHER ISSUE. THE DEVICE WAS RETURNED TO THE MANUFACTURER, 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 THE PT WAS EXPERIENCING QUESTIONABLE VAD READINGS. THE DECISION WAS MADE BY THE DOCTOR TO EXCHANGE THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 101930

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention