BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3111366 · Received May 9, 2013

    Report

    Report Number
    2916596-2013-00551
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 11, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'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 DEVELOPED AN INFECTION POST-OP AND THEN EXPERIENCED AN INTRACRANIAL HEMORRHAGIC AND ISCHEMIC STROKE. THE PT IS CURRENTLY HOSPITALIZED AND BEING MONITORED IN THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204903 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIT DEVICE DSQ THORATEC CORP. 104911 120583

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention