BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1000471 · Received February 21, 2008

    Report

    Report Number
    2916596-2008-00020
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 18, 2008
    Report Date
    January 22, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING WITH THE LVAD AND IS CURRENTLY BEING TREATED FOR THE INFECTION WITH ANTIBIOTICS. NO FURTHER INFO 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 PT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE HOSPITAL THAT THE PUMP RATE HAD SLOWLY INCREASED TO 120 BPM. X-RAY AND VENT FILTER ANALYSIS WERE NOTED TO BE INDICATING PUMP END OF LIFE SYMPTOMS. A DECISION WAS MADE TO REPLACE THE LVAD WITH THE MANUFACTURER'S CLINICAL TRIAL LVAD. HOWEVER, DUE TO THE PT PRESENTING WITH AN INFECTION, THE PUMP EXCHANGE DATE HAS NOT YET BEEN DETERMINED.

    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 36 YR Required Intervention