BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1012687 · Received March 12, 2008

    Report

    Report Number
    2916596-2008-00033
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS STABLE ON PNEUMATIC SUPPORT AWAITING A HEART TRANSPLANT. 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 WHILE THE PATIENT WAS AT HOME, HE REPORTED EXPERIENCING POWER LIMIT ADVISORY AND MULTIPLE RED HEART ALARMS AND EXCHANGED THE SYSTEM CONTROLLER WITH NO RESOLVE. WHILE AT THE HOSPITAL, THE PATIENT CONTINUED TO EXPERIENCE INCREASING ALARMS WHILE SUPPORTED ON TWO SEPARATE POWER BASE UNITS (PBU). WAVEFORMS WERE OBTAINED AND SENT TO THE MANUFACTURER FOR ANALYSIS AND THE PATIENT WAS PLACED ON PNEUMATIC SUPPORT USING AN IP CONSOLE AND STROKE VOLUME LIMITER (SVL).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention