BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1012684 · Received March 12, 2008

    Report

    Report Number
    2916596-2008-00031
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 20, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE PERFUSIONIST THAT THE PT WAS ADMITTED TO THE HOSPITAL AND PLACED ON PNEUMATIC SUPPORT USING AN IP CONSOLE AND STROKE VOLUME LIMITER (SVL) DUE TO SUSPECTED PUMP END OF LIFE. THE PT WAS SUCCESSFULLY TRANSPLANTED IN 2008.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention