BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3030182 · Received March 28, 2013

    Report

    Report Number
    2916596-2013-00292
    Event Type
    Death
    Date Received
    March 28, 2013
    Date of Event
    December 18, 2012
    Report Date
    February 27, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT EXPIRED AND NO AUTOPSY WAS PERFORMED. THE USER FACILITY REPORT # (B)(4) WAS RECEIVED FROM (B)(6). NO FURTHER INFORMATION 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. THE VAD COORDINATOR REPORTED THAT THE PT EXPERIENCED POWER ELEVATIONS AND HEMOLYSIS. THE PT ALSO EXPERIENCED A DRIVELINE INFECTION. THE PT WAS ADMITTED AND ADMINISTERED MEDICATION, BUT DEVELOPED AN INTRACRANIAL BLEED. THE PT WAS WITHDRAWN FROM SUPPORT AND EXPIRED ON (B)(6) 2013 AND NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128720 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 98916

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death