BEUDAMED
    FDA Adverse Event Death Summary report: N

    HM II LVAS EUROPE

    MDR report key: 1686140 · Received May 12, 2010

    Report

    Report Number
    2916596-2010-00113
    Event Type
    Death
    Date Received
    May 12, 2010
    Date of Event
    April 14, 2010
    Report Date
    April 22, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER 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 MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. AFTER APPROXIMATELY 3 YEARS ON THE DEVICE, THE PT WAS FOUND DEAD AT HOME, PRESUMABLY HAVING FALLEN ASLEEP WHILE ON THE BATTERY SUPPORT. THE HOSPITAL BELIEVES THAT THE REASON THE PT EXPIRED WAS THAT THE BATTERIES WERE DEPLETED WHILE THE PT WAS ASLEEP AND THE PUMP STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HM II LVAS EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 102139 59042

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death