BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2880272 · Received December 19, 2012

    Report

    Report Number
    2880272
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    October 30, 2012
    Report Date
    December 18, 2012
    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

    SET SPEED FLUCTUATIONS 9140-9190 FROM SET SPEED OF 9200, HIGH LDH LEVELS, HIGH PI. INCREASING RPMS DID NOT CAUSE PI TO DECREASE. PERFORMED A HMII PUMP EXCHANGE WITH SUCCESS. EXPLANTED PUMP SHOWED DENATURED PROTEIN THROMBUS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1