BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3111357 · Received May 9, 2013

    Report

    Report Number
    2916596-2013-00549
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 2, 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
    HOME HEALTH AIDE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PT. 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 DAY AFTER THE PT'S PUMP WAS IMPLANTED, THE PT EXPERIENCED A RIGHT FRONT LOBE INFARCTION. THE PT IS BEING MONITORED, INCLUDING MONITORING HIS INTERNATIONAL NORMALIZED RATIO (INR) LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204612 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 124864

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention