BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2922490 · Received January 11, 2013

    Report

    Report Number
    2916596-2013-00041
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    October 29, 2012
    Report Date
    December 15, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PT. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MFR REC'D THE USER FACILITY REPORT ((B)(4)) FROM THE INTERMACS REGISTRY. THE REPORT INDICATED THAT THE PT EXPERIENCED HEMOLYSIS. THE ECHO SHOWED AORTIC VALVE OPENED 100 PERCENT OF THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18240 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 93942

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other