BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2843483 · Received November 19, 2012

    Report

    Report Number
    2916596-2012-01127
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    May 26, 2011
    Report Date
    October 24, 2012
    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 PUMP REMAINS IN USE SUPPORTING THE PT. NO FURTHER INFO 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT HAS HAD ISSUES WITH DRIVELINE INFECTIONS FOR OVER A YEAR AND A HISTORY OF BLEEDING. THE DRIVELINE INFECTIONS HAD IMPROVED TWO MONTHS AGO WITH 3 TREATMENTS PER WEEK; HOWEVER, THE PT HAS BEEN STARTED ON ANTICOAGULATION MEDICATION DUE TO A LEFT VENTRICLE (LV) THROMBUS. THE PT CONTINUES TO HAVE ISSUES WITH DRIVELINE INFECTIONS BUT IS AT HOME AND STABLE. THE HOSPITAL STAFF WILL CONTINUE TO MONITOR THE DRIVELINE INFECTIONS WITH ANTIBIOTICS AND WILL ALSO MONITOR THE PT'S INTERNATIONAL NORMALIZED RATIO (INR) AS WELL AS THE LV THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 82643

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention