BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2485660 · Received March 7, 2012

    Report

    Report Number
    2916596-2012-00215
    Event Type
    Malfunction
    Date Received
    March 7, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 9, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    2916596-02/24/2012-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON GOING 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 BIO-MED ENGINEER THAT DURING A ROUTINE CHEST X-RAY OF THE PATIENT, IT WAS DISCOVERED THAT THE OUTFLOW BEND RELIEF DID NOT APPEAR TO BE CONNECTED. THE METAL PORTION OF THE BEND RELIEF WAS ABOVE AND AT AN ANGLE FROM THE OUTFLOW GRAFT CONNECTION. IT WAS NOTED THAT THE PATIENT IS DOING WELL AND NOT EXHIBITING ANY SIGNS OF KINKS OR OBSTRUCTION. THERE ARE PLANS TO TAKE THE PATIENT BACK TO THE OPERATING ROOM TO ATTACH THE OUTFLOW BEND RELIEF. A CHEST X-RAY WAS SENT TO THE MANUFACTURER FOR REVIEW. INSTRUCTIONS BY THE MANUFACTURER WERE GIVEN TO THE MEDICAL STAFF TO ENSURE THAT THE BEND RELIEF IS APPROPRIATELY AND FULLY ENGAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 11118

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other