BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3486049 · Received November 14, 2013

    Report

    Report Number
    2916596-2013-01527
    Event Type
    Injury
    Date Received
    November 14, 2013
    Date of Event
    October 15, 2013
    Report Date
    October 16, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 WAS ADMITTED INTO THE HOSPITAL AND FELT THAT PT HAD SIGNS OF NON-OBSTRUCTING PUMP THROMBUS. THE PT'S PLASMA FREE HEMOGLOBIN WAS 21, AND LACTATE DEHYDROGENASE (LDH) WAS 800-900. THE PT WAS TREATED WITH AGGRENOX, ASA AND COUMADIN. THE PT UNDERWENT A CARDIAC TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590719 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 126035

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention