BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2172572 · Received July 20, 2011

    Report

    Report Number
    2916596-2011-00310
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 13, 2011
    Report Date
    July 12, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 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). THE PERFUSIONIST REPORTED THAT THE LVAD WOULD NOT UNLOAD THE PT'S LEFT VENTRICLE DESPITE INCREASING THE PUMP SPEED. THE HOSPITAL SUSPECTED THROMBUS IN THE DEVICE AND AS A RESULT MADE A DECISION TO EXCHANGE THE LVAD WITH ANOTHER LVAD. IT WAS REPORTED THAT UPON EXPLANT, THROMBUS WAS OBSERVED ON THE DEVICE. THE PT REMAINS ONGOING ON LVAD SUPPORT WITHOUT ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 97713

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention