BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3233660 · Received July 16, 2013

    Report

    Report Number
    2916596-2013-00865
    Event Type
    Death
    Date Received
    July 16, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 25, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT EXPIRED AND IT WAS REPORTED THAT NO AUTOPSY WAS PERFORMED. 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. THE VAD COORDINATOR REPORTED THAT THE PATIENT SUFFERED AN ACUTE EVENT OF A CEREBRAL HEMORRHAGE AND EXPIRED ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT WAS OFF ANTICOAGULATION MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330398 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 109736

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death