BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2426120 · Received January 17, 2012

    Report

    Report Number
    2916596-2012-00047
    Event Type
    Death
    Date Received
    January 17, 2012
    Date of Event
    December 19, 2011
    Report Date
    December 19, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S FAMILY REFUSED AN AUTOPSY; THEREFORE, THE PUMP WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE SYSTEM CONTROLLER IN USE AT THE TIME OF THE EVENT FOR ANALYSIS. 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. APPROXIMATELY 2 MONTHS POST-IMPLANT, THE PATIENT WAS FOUND EXPIRED AT HOME WITH BOTH POWER LEADS DISCONNECTED. ACCORDING TO THE INFORMATION PROVIDED, NO ALARMS WERE HEARD FROM THE SYSTEM CONTROLLER WHEN THE PATIENT WAS INITIALLY FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 108201

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death