BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2720000 · Received August 29, 2012

    Report

    Report Number
    2720000
    Event Type
    Injury
    Date Received
    August 29, 2012
    Report Date
    August 29, 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

    PT WITH KNOWN OUTFLOW BEND RELIEF DISRUPTION PRESENTED WITH BLOOD FROM DRIVELINEEXIT SITE AND RECTUS SHEATH HEMATOMA OVER AREA OF OUTFLOW BEND RELIEF PER CTSCAN. ELECTIVE EXCISION AND REPLACEMENT OF OBR PERFORMED VIA ABDOMINAL APPROACH.

    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