BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2933128 · Received January 25, 2013

    Report

    Report Number
    2916596-2013-00084
    Event Type
    Death
    Date Received
    January 25, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 27, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNING TO THE MANUFACTURER FOR EVALUATION. 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 (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT RECENTLY HAD A CEREBRAL BLEED AND A DRIVELINE INFECTION. THE PATIENT WAS PLACED IN HOSPICE CARE. WHILE IN HOSPICE CARE THE PATIENT AND HER FAMILY DECIDED TO WITHDRAW PUMP SUPPORT, AND THE PATIENT EXPIRED. THE PUMP WAS NOT EXPLANTED AS THE PATIENT'S FAMILY DID NOT WANT AN AUTOPSY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36149 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 84561

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death