BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3240122 · Received July 18, 2013

    Report

    Report Number
    2916596-2013-00925
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    April 29, 2013
    Report Date
    June 20, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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). THE HOSPITAL REPORTED THAT, AFTER APPROXIMATELY 15 MONTHS OF SUPPORT, THE PT EXPERIENCED A NEUROLOGICAL EVENT. THE PT WAS DIAGNOSED WITH A CEREBRAL VASCULAR EVENT. THE PT HAD NO NEUROLOGICAL STATUS AT THE TIME AND WAS GOING TO BE TRANSFERRED TO A NURSING HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334142 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 120264

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other