BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2885000 · Received December 19, 2012

    Report

    Report Number
    2916596-2012-01222
    Event Type
    Death
    Date Received
    December 19, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 22, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR WAS ADVISED THAT THE LVAD PUMP WILL NOT BE EXPLANTED DUE TO THE REQUEST MADE BY THE FAMILY. NO FURTHER INFO 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT HAD BECOME NONRESPONSIVE WHILE AT HOME. EMERGENCY MEDICAL SERVICES (EMS) AND THE EMERGENCY ROOM (ER) BROUGHT HIM BACK WITH LIFE SUPPORT. THERE WERE NO ABNORMAL EVENTS OR ALARMS ON THE HISTORY LOG OF THE SYSTEM CONTROLLER. ADDITIONAL INFO WAS RECEIVED 3 DAYS LATER STATING THAT SUPPORT WAS WITHDRAWN ON (B)(6) 2012 AND THE PT EXPIRED. THE LVAD PUMP WILL NOT BE RETURNED DUE TO THE PT'S FAMILY REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 111845

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death