BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE

    MDR report key: 2180396 · Received July 27, 2011

    Report

    Report Number
    2180396
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    September 3, 2008
    Report Date
    September 27, 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 PUMPADDITIONAL TEXT: BEARING FAILURESPECIFIC COMPONENT(S) INVOLVED: PUMP DRIVE UNIT MALFUNCTIONADDITIONAL TEXT: BEARING FAILUREOTHER COMPONENT:CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIEDOTHER CAUSE:INTERVENTION(S): REPLACEMENT OF PUMPOTHER INTERVENTION :IMPLANT DEVICE TYPE: LVADMALFUNCTION DEVICE TYPE:

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMPSPECIFIC COMPONENT(S) INVOLVED: PUMP DRIVE UNIT MALFUNCTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE XVE LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65.1 YR