BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2467595 · Received February 22, 2012

    Report

    Report Number
    2916596-2012-00167
    Event Type
    Death
    Date Received
    February 22, 2012
    Date of Event
    January 21, 2012
    Report Date
    January 26, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVALUATION. 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). THE VAD COORDINATOR ADMINISTRATOR REPORTED THAT THE PT WAS FOUND DECEASED AT HOME WITH BOTH POWER LEADS DISCONNECTED. THE PT'S CAUSE OF DEATH WAS NOT REPORTED TO THE MFR AND NO ADDITIONAL INFO REGARDING THE EVENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 109104

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Death