BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3840502 · Received May 14, 2014

    Report

    Report Number
    2916596-2014-00781
    Event Type
    Death
    Date Received
    May 14, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 14, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE AND OBTAIN ADD'L INFO REGARDING THE REPORTED EVENT. 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 (LVAD). INFO WAS PROVIDED TO THE MFR THOUGH THEIR DEVICE TRACKING SYSTEM INDICATING THAT PT EXPIRATION OCCURRED ON (B)(6) 2012. THE CAUSE OF THE DEATH WAS NOTED AS SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287964 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1355 51502

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death