BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1111888 · Received August 12, 2008

    Report

    Report Number
    2916596-2008-00109
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 14, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS STABLE ON THE LVAD. THE DEVICE WAS SENT TO THE MANUFACTURER FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS 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 PATIENT WAS HOSPITALIZED FOR PULMONARY ISSUES AND FEVER. WHEN THE LVAD WAS OPERATING IN AUTO MODE THE PATIENT'S HEART RATE DECREASED TO 50 AND THE PATIENT EXPERIENCED DIFFICULTY BREATHING; THEREFORE, THE PATIENT WAS PUT IN FIXED MODE AT A RATE OF 75. IT WAS ALSO REPORTED THAT THE SYSTEM MONITOR DISPLAYED A RATE CONTROL FAULT ALARM. THE WAVEFORMS WERE THEN EVALUATED IN BOTH MODES AND NO ABNORMALITIES WERE NOTED. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE VENT FILTER WAS ANALYZED. DURING THE FOLLOWING 2 WEEKS, THE VENT FILTER DEMONSTRATED AN INCREASE IN DUST AND REQUIRED DAILY CHANGES. A DECISION WAS THEN MADE TO EXCHANGE THE PUMP, AND THE PATIENT'S LVAD WAS REPLACED WITH ANOTHER LVAD. THE PATIENT REMAINS ONGOING WITH THE MANUFACTURER'S 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 49 YR Required Intervention