BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3072853 · Received April 23, 2013

    Report

    Report Number
    3072853
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 28, 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

    PT PRESENTED WITH DARK URINE THAT STARTED ON (B)(6) 2013. VAD FUNCTION NORMAL AS FAR AS PT CAN TELL. PT WAS ADMITTED FOR EVAL FOR POTENTIAL VAD THROMBUS. DURING HOSP. PT TREATED FOR SUSPECTED THROMBUS HOWEVER NO EVIDENCE OF THROMBUS WAS NOTED BY D/C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173742 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1