BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3862729 · Received May 22, 2014

    Report

    Report Number
    2916596-2014-00818
    Event Type
    Death
    Date Received
    May 22, 2014
    Date of Event
    June 25, 2013
    Report Date
    April 21, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT THE PT EXPIRED DUE TO A CEREBROVASCULAR ACCIDENT (CVA). THE CVA WAS ATTRIBUTED TO SUBDURAL HEMATOMA AND NOT LIKELY TO HAVE BEEN RELATED TO THE DEVICE. IT WAS ALSO REPORTED THAT THE PT'S INTERNAL NORMALIZED RATIO (INR) WAS 2.4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306943 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 109870

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death