BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 4121152 · Received July 28, 2014

    Report

    Report Number
    2916596-2014-01119
    Event Type
    Death
    Date Received
    July 28, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 29, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING WITH THE IMPLANTED DEVICE. 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 HAD A VERY SMALL VENTRICLE AND WAS EXPERIENCING CONSTANT LOW FLOW ALARMS. THE VAD COORDINATOR NOTED THAT THIS PT SHOULD NOT HAVE BEEN IMPLANTED WITH AN LVAD. IT WAS ALSO NOTED THAT THE PT HAS A RESTRICTIVE LEFT VENTRICLE AND THE PUMP ITSELF SEEMED TO BE SHIFTED TOWARDS THE SEPTUM. THE PT HAD A LOW SPEED ALARM THAT CORRELATED WITH A PI EVENT RECENTLY. THE LOG FILE SHOWED MULTIPLE LOW FLOW HAZARD ALARMS, AND A LOW SPEED OPERATION ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439987 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 140950

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Death