BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3111285 · Received May 9, 2013

    Report

    Report Number
    2916596-2013-00534
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    January 17, 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 PATIENT REMAINS ONGOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT EXPERIENCED A STROKE ON (B)(6) 2013, TO THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE PATIENT'S INTERNATIONAL NORMALIZED RADIO (INR) WAS 2 AROUND THE TIME OF EVENT. THE PATIENT'S BLOOD PRESSURE HAS BEEN MAINTAINED SINCE THE PATIENT HAS A HISTORY OF BEING HYPERTENSIVE. HIS ANTICOAGULATION IS ALSO BEING MONITORED. THE PATIENT IS 95% BACK TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204990 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 114705

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention