BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2092640 · Received May 10, 2011

    Report

    Report Number
    2916596-2011-00179
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT EXPERIENCED INTERMITTENT RED HEART ALARMS WITH POSITION CHANGES. THE PT'S SYSTEM CONTROLLER WAS EXCHANGED WITHOUT RESOLUTION. IT WAS NOTED THAT THE PUMP SPEED DROPPED WHENEVER THE PT TRIED TO GET OUT OF BED, AND HE FELT A "FLUTTERING" IN HIS CHEST. THE PT HAS A PSEUDOMONAS DRIVELINE INFECTION. THE ALARMS AND SPEED DID NOT STABILIZE WHILE ON BATTERY POWER. THE X-RAYS WERE REVIEWED AND INDICATIONS OF THE PUMP END BEND RELIEF SHIELDING STRESS WAS NOTED. THE PT WAS MOVED UP ON THE TRANSPLANT LIST (1A) AND WAS TRANSPLANTED THREE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 91899

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other