BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2190684 · Received July 26, 2011

    Report

    Report Number
    2916596-2011-00316
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 7, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE SURGEON REPORTED THAT THE PATIENT PRESENTED WITH HEMOLYSIS AND THE HOSPITAL SUSPECTED THROMBUS IN THE DEVICE. BASED ON THE HOSPITAL'S CLINICAL JUDGMENT, A DECISION WAS MADE TO EXPLANT THE LVAD FOR RECOVERY OF THE PATIENT'S NATURAL HEART. IT WAS REPORTED THAT UPON EXPLANT, THERE WAS NO THROMBUS OBSERVED ON THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 104107

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention