BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3942612 · Received July 17, 2014

    Report

    Report Number
    3942612
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    March 9, 2014
    Report Date
    July 14, 2014
    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

    PATIENT HAS HAD MULTIPLE MEDIASTINAL DEBIDEMENTS (B)(6) 2014, (B)(6) 2014, (B)(6) 2014, (B)(6) 2014. RETURNED TO OR ON (B)(6) 2014 FOR SHORTING OF LVAD OUTFLOW GRAFT FOR KNOWN KINK ON OUTFLOW GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418352 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1