BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1040092 · Received May 7, 2008

    Report

    Report Number
    2916596-2008-00059
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 18, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING WITH THE MFR'S CLINICAL TRIAL LVAD. THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION 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 VAD DIRECTOR, THAT THE PT BEGAN EXPERIENCING SYMPTOMS OF PUMP END OF LIFE. A VENT FILTER WAS SUBMITTED FOR ANALYSIS WHICH REVEALED POSSIBLE MAIN BEARING WEAR AND APPROXIMATELY ONE WEEK LATER, NOISES WERE HEARD COMING FROM THE PUMP. A DECISION WAS MADE TO REPLACE THE LVAD WITH THE MFR'S CLINICAL TRIAL LVAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention