BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1180489 · Received September 26, 2008

    Report

    Report Number
    2916596-2008-00134
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 28, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVAL. FUNCTIONAL TESTING OF THE PUMP UNDER NORMAL OPERATING CONDITIONS REVEALED THAT THE PUMP WAS OPERATING WITH HIGHER THAN NORMAL PUMP POWER CONSUMPTION. VISUAL INSPECTION OF THE PUMP ASSEMBLY REVEALED EXTENSIVE WEAR THAT OCCURRED TO THE INTERNAL COMPONENTS OF THE LOWER MAIN BEARING WHICH APPEARED TO CONTRIBUTE TO SIGNIFICANT ROTOR DRAG, AND THE HIGH PUMP POWER CONSUMPTION RESULTING IN THE REPORTED EVENT. BEARING ISSUES ARE CURRENTLY BEING ADDRESS THROUGH THE MANUFACTURER'S DESIGN CHANGE SYSTEM. NO FURTHER INFO IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). INFO WAS PROVIDED TO THE MANUFACTURER THAT DUE TO PUMP NOISE AND THE VENT FILTER ANALYSIS A DECISION WAS MADE TO EXCHANGE THE PT'S LVAD WITH ANOTHER LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE XVE LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1270 46193

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention