BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3111110 · Received May 9, 2013

    Report

    Report Number
    2916596-2013-00544
    Event Type
    Death
    Date Received
    May 9, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 11, 2013
    Manufacturer
    THORATEC CORPORATION
    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, AS IT WAS NOT EXPLANTED. 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT HAD BEEN DISCHARGED TO AN OUTPATIENT FACILITY. THE PATIENT HAD AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), AND WAS TRACHED. THE PATIENT DEVELOPED AN INTRACRANIAL BLEED WHILE AT THE OUTPATIENT FACILITY AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202700 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 121706

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death