BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2951132 · Received February 8, 2013

    Report

    Report Number
    2951132
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    July 29, 2011
    Report Date
    February 8, 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

    DEBRIDEMENT OF LVAD DRIVELINE INFECTION, INCLUDING SKIN, SUBCUTANEOUS TISSUE AND MUSCLE/REMOVAL OF ANTIBIOTIC BEADS/COVERAGE OF LVAD DRIVELINE WITH FASCIOCUTANEOUS FLAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54083 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1