BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2010471 · Received March 1, 2011

    Report

    Report Number
    2916596-2011-00083
    Event Type
    Death
    Date Received
    March 1, 2011
    Date of Event
    January 15, 2011
    Report Date
    February 1, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE MANUFACTURER'S CLINICAL REPRESENTATIVE THAT THE SURGEON REPORTED THAT HIS PT HAD EXPIRED AFTER TWO DAYS FROM THE DATE OF IMPLANT. HE HAS REQUESTED THAT THE MFR EVALUATE THE LVAD PUMP. NO FURTHER INFO WAS GIVEN TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 100443

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death