BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3022048 · Received March 26, 2013

    Report

    Report Number
    3022048
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 25, 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

    WATT SPIKES. VAD PARAM WNL, HX SHOWED PI EVENTS, 2 SXN EVENT. W/H ANTIHYPERTENS AND DIURETICS 24 HRS. VOLM LOSS COULD CAUSE LOW BLD PRESS.PI PRESS AND PWR INCR. SPEED DECR. TO 9000 RPM. PT BETTER IN F/U ON DAY AFTER D/C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123393 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1