BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2502508 · Received March 23, 2012

    Report

    Report Number
    2502508
    Event Type
    Injury
    Date Received
    March 23, 2012
    Date of Event
    August 31, 2011
    Report Date
    September 13, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: DEVICE THROMBOSIS. SPECIFIC COMPONENT(S) INVOLVED: INFLOW GRAFT MALFUNCTION/MALPOSITION; OUTFLOW GRAFT MALFUNCTION/MALPOSITION, PUMP DRIVE UNIT MALFUNCTION.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: DEVICE THROMBOSIS. ADDITIONAL TEXT: W/INGESTED COSEAL (HYDROGEL); THROMBUS IN ROTOR, OUTLET STATOR, OUTLET BEARINGS. SPECIFIC COMPONENT(S) INVOLVED: INFLOW GRAFT MALFUNCTION/MALPOSITION; OUTFLOW GRAFT MALFUNCTION/MALPOSITION; PUMP DRIVE UNIT MALFUNCTION. ADDITIONAL TEXT: P/N 102564, L/N 102151; ABUTTING LV FREE WALL; P/N 102563, L/N 102006; LARGE BEND/LONG LENGTH; HEARTMATE II LVAD, S/N (B)(4); THROMBOSED AS ABOVE. CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. INTERVENTION(S): REPLACEMENT OF INFLOW GRAFT; REPLACEMENT OF OUTFLOW GRAFT; REPLACEMENT OF PUMP. IMPLANT DEVICE TYPE: LVAD.

    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 24.5 YR