BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2091897 · Received May 18, 2011

    Report

    Report Number
    2091897
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    May 11, 2011
    Report Date
    August 9, 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: DEVICE THROMBOSISSPECIFIC COMPONENT(S) INVOLVED: PUMP DRIVE UNIT FAILURE

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: DEVICE THROMBOSIS. ADDITIONAL TEXT: SUSPECTED PUMP THROMBOSIS. SPECIFIC COMPONENT(S) INVOLVED: PUMP DRIVE UNIT MALFUNCTION. ADDITIONAL TEXT: PUMP. OTHER COMPONENT: CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. OTHER CAUSE: INTERVENTION(S): REPLACEMENT OF PUMP. OTHER INTERVENTION : 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 62.4 YR