BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3053434 · Received April 11, 2013

    Report

    Report Number
    3053434
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 8, 2013
    Report Date
    April 11, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED WITH FATIGUE, DARK URINE. FOUND TO HAVE LOW HGB, ELEVATED PF HGB, WORSENING RIGHT HEART FUNCTION BY RHC, ECHO. POOR RESPONSE TO MED MANAGEMENT. NOT A SURGICAL CANDIDATE FOR NEW DEVICE OR TRANSPLANT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154457 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1