BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3020534 · Received March 21, 2013

    Report

    Report Number
    2916596-2013-00302
    Event Type
    Death
    Date Received
    March 21, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 20, 2013
    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 EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED,.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A VENTRICULAR SEPTAL DEFECT (VSD) AND WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE PATIENT SHOWED SIGNS OF PUPIL DILATATION WITH POSSIBLE NEURO INVOLVEMENT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM (O.R.) FOR VSD REPAIR AND THE CONDITION DETERIORATED. THE PATIENT EXPIRED. THE EXPLANTED PUMP WILL BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118768 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 120266

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death