BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3080940 · Received April 17, 2013

    Report

    Report Number
    2916596-2013-00440
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS 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 AN LVAD PUMP EXCHANGE IS PLANNED AS THE PT HAS HAD A HISTORY OF CAROTID CLOT WITH CLOT REMOVAL, STROKE, AND HEMOLYSIS SINCE ORIGINAL IMPLANT. PT HAD EXTENSIVE WORK UP FOR HEMOLYSIS AND NO CAUSE WAS FOUND AND PT FELT FINE. RECENTLY, PT'S URINE WAS SHOWING EVIDENCE OF HEMOLYSIS AND LACTATE DEHYDROGENASE (LDH) WAS VERY HIGH COMPARED TO BASELINE >4000. THE PT UNDERWENT A SUCCESSFUL LVAD EXCHANGE ON (B)(6) 2013. IT WAS NOTED THAT THE PUMP WAS EXCHANGED SUBCOSTALLY AND BOTH THE ORIGINAL INFLOW CONDUIT AND OUTFLOW GRAFTS WERE LEFT IN PLACE. THE USER FACILITY REPORT 3800090000-2013-9014 WAS RECEIVED FROM THE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167005 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 100857

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention