BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1910276 · Received November 18, 2010

    Report

    Report Number
    2916596-2010-00305
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    August 11, 2010
    Report Date
    October 22, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PUMP HAD REACHED THE END OF ITS LIFE; THEREFORE THE PATIENT'S PUMP WAS EXCHANGED WITH ANOTHER LVAD. THE PATIENT REMAINS ONGOING ON THE NEW LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE XVE LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 1270 66293

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention