BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3181296 · Received June 13, 2013

    Report

    Report Number
    2916596-2013-00771
    Event Type
    Injury
    Date Received
    June 13, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 17, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHED USER FACILITY REPORT #(B)(4), WAS RECEIVED FROM THE (B)(4). THE PT CONTINUES ON LVAD SUPPORT. 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

    AN (B)(4) REPORT WAS RECEIVED WHICH INDICATED THAT THE PT ARRIVED TO CLINIC WITH ABNORMAL SPEEDS. AN ECHOCARDIOGRAM (ECHO) WAS PERFORMED AND THE AORTIC VALVE WAS OPENING. A CLOT WAS SUSPECTED DURING THE ECHO. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED IN INTENSIVE CARE UNIT (ICU) AND SPEEDS AS WELL AS THE FLOW RETURNED TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269641 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 119679

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention