BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2431762 · Received January 26, 2012

    Report

    Report Number
    2916596-2012-00101
    Event Type
    Death
    Date Received
    January 26, 2012
    Date of Event
    December 17, 2011
    Report Date
    December 30, 2011
    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 DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION, AS IT WAS DISPOSED OF. 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 HAD PERSISTENT BLEEDING. THE HOSPITAL WENT FOR RE-EXPLORATION WITH EVIDENCE OF BLEEDING. THE PATIENT WAS ASSESSED BY NEUROLOGY WITH A HIGH DEGREE OF ANOXIC BRAIN DAMAGE SUSPICION. THE PATIENT EXPIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death