BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC PVAD

    MDR report key: 2001234 · Received February 24, 2011

    Report

    Report Number
    2001234
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    November 19, 2010
    Report Date
    May 3, 2011
    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: BLOOD PUMP; DEVICE THROMBOSIS. ADDITIONAL TEXT: RVAD; RVAD OUTFLOW THROMBUS. SPECIFIC COMPONENT(S) INVOLVED: OUTFLOW GRAFT MALFUNCTION/MALPOSITION. ADDITIONAL TEXT: RVAD BLOOD PUMP/OUTFLOW THROMBUS. OTHER COMPONENT: CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. OTHER CAUSE: INTERVENTION(S): REPLACEMENT OF PUMP. OTHER INTERVENTION : IMPLANT DEVICE TYPE: BOTH (IN THE SAME OR VISIT). MALFUNCTION DEVICE TYPE: RVAD.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMP; DEVICE THROMBOSISSPECIFIC COMPONENT(S) INVOLVED: OUTFLOW GRAFT MALFUNCTION/MALPOSITION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC PVAD BIVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23.2 YR