BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 5993895 · Received October 3, 2016

    Report

    Report Number
    2916596-2016-01896
    Event Type
    Death
    Date Received
    October 3, 2016
    Date of Event
    June 3, 2016
    Report Date
    September 6, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 88 DAYS. NO EQUIPMENT WAS RETURNED FOR EVALUATION. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2016. IT WAS REPORTED THAT AFTER APPROXIMATELY 88 DAYS OF SUPPORT, THE PATIENT WAS FOUND DOWN AT HOME WITH LOW FLOW ALARMS SOUNDING FROM THE SYSTEM CONTROLLER. THE PATIENT WAS FOUND TO HAVE AN ANOXIC BRAIN INJURY. AFTER TWO WEEKS OF NO RECOVERY, CARE WAS WITHDRAWN AND THE PATIENT EXPIRED ON (B)(6) 2016. IT WAS REPORTED THAT THE DEVICE WAS WORKING AS EXPECTED. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE PATIENT'S FAMILY AND NO EQUIPMENT OR LOG FILES WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646805 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| H| R