BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2831236 · Received November 6, 2012

    Report

    Report Number
    2916596-2012-01072
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS SUCCESSFULLY EXCHANGED AND THE PT CONTINUES ON LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED. THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MANUFACTURER RECEIVED A REPORT THROUGH DEVICE TRACKING INDICATING THAT THE HOSPITAL HAD EXCHANGED THE PT'S PUMP WITH ANOTHER LVAD DUE TO HEMOLYSIS. ADDITIONAL INFORMATION PROVIDED BY THE VAD COORDINATOR INDICATED THAT THE HEMOLYSIS WAS RELATED TO SUSPECTED THROMBUS IN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 95152

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention