BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 1850567 · Received July 20, 2010

    Report

    Report Number
    2916596-2010-00184
    Event Type
    Injury
    Date Received
    July 20, 2010
    Date of Event
    June 26, 2010
    Report Date
    June 26, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 SURGEON THAT THE PT APPEARED TO HAVE A PUMP THROMBUS. THE PT CODED AND THEY WERE ABLE TO RETURN THE PT TO SINUS RHYTHM. THE PT WAS TAKEN BACK TO THE OPERATING ROOM AND ECMO WAS PLACED THROUGH THE GROIN. THE OUTFLOW GRAFT WAS DISSECTED AND STAPLED AND THE HEARTMATE II LVAD WAS TURNED OFF AND THE PERC LEAD DISCONNECTED FROM THE SYSTEM CONTROLLER. THE PUMP REMAINED IN THE PT AND A PUMP EXCHANGE WAS PLANNED AFTER THE PT WOKE UP AND THE NEURO STATUS WAS CONFIRMED. A PUMP EXCHANGE FROM ONE LVAD TO ANOTHER LVAD TOOK PLACE 9 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 89471

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention