BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2516880 · Received April 4, 2012

    Report

    Report Number
    2516880
    Event Type
    Death
    Date Received
    April 4, 2012
    Date of Event
    June 2, 2011
    Report Date
    July 5, 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: BLOOD PUMP. SPECIFIC COMPONENT(S) INVOLVED: PUMP DRIVE UNIT MALFUNCTION.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMP. ADDITIONAL TEXT: INC POWER->PUMP STOPPAGE. SPECIFIC COMPONENT(S) INVOLVED: PUMP DRIVE UNIT MALFUNCTION. ADDITIONAL TEXT: HMII LVAD, P/N 29257, S/N (B)(4). OTHER COMPONENT: CAUSATIVE OR CONTRIBUTING FACTOR: PATIENT NON-COMPLIANCE IN DEVICE MAINTENANCE/PROTECTION. OTHER CAUSE: INTERVENTION(S): NONE. OTHER INTERVENTION : IMPLANT DEVICE TYPE: LVAD. MALFUNCTION DEVICE TYPE:.

    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 54.1 YR Death