BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3072311 · Received April 19, 2013

    Report

    Report Number
    2916596-2013-00458
    Event Type
    Death
    Date Received
    April 19, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 22, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER 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 AN ACUTE BLOOD PUMP SYSTEM AND LVAD PUMP FOR BIVENTRICULAR SUPPORT. THE PATIENT REMAINED CRITICALLY ILL SINCE IMPLANT WITH AT LEAST ONE STROKE. TRANSPLANT WAS NO LONGER AN OPTION AND SUPPORT WAS WITHDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170417 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 116729

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death