BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2932249 · Received January 25, 2013

    Report

    Report Number
    2916596-2013-00085
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 27, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 SURGEON THAT THE PT'S PUMP WAS EXPLANTED FOR RECOVERY. THE PT'S EJECTION FRACTION (EF) WAS 68%. WEANING ECHO STUDY WAS PERFORMED WHILE THE PT WAS EXERCISING. IT WAS ALSO REPORTED THAT THE PUMP WILL BE RETURNED TO THE MANUFACTURER FOR EVAL FOR THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36079 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 102063

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other