BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2497264 · Received March 12, 2012

    Report

    Report Number
    2916596-2012-00063
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    November 30, 2011
    Report Date
    February 23, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165962/24/12001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SITUATION IS BEING ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (2916596-2/24/12-001-C) WAS SENT TO CUSTOMERS. THE DEVICE WAS RETURNED TO THE MANUFACTURER, AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS 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 THE PATIENT RECEIVED A HEART TRANSPLANT, AND WHEN THE PUMP WAS EXPLANTED IT WAS NOTED THAT THE OUTFLOW BEND RELIEF WAS NOT ATTACHED TO THE PUMP. TISSUE WAS ALSO NOTED TO BE OVER THE INFLOW GRAFT. THE PATIENT DID NOT DISPLAY ANY SIGNS OF REDUCED FLOWS OR REDUCTIONS IN POWER DUE TO THE TISSUE GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 97605

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other