BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2963446 · Received February 13, 2013

    Report

    Report Number
    2916596-2013-00181
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 18, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER OR 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS ADMITTED FOR LOW FLOW AND DEHYDRATION. NO POWER ELEVATIONS WERE NOTED AND THE PATIENT WAS MOVED UP ON THE TRANSPLANT LIST. THE PATIENT DEVELOPED CLOSTRIDIUM DIFFICILE INFECTION AND CONTINUED TO DETERIORATE. LABS WERE NORMAL. THE PATIENT HAD FLOWS OF 6L/MIN AT HOME BUT IT APPEARED THAT FLOWS DIDN'T DROP TO 2.5L/MIN TO TRIGGER AN ALARM. AN ECHOCARDIOGRAM (ECHO) SHOWED RIGHT VENTRICLE AND LEFT VENTRICLE DYSFUNCTION. THE LVAD PUMP WAS EXCHANGED WITH ANOTHER LVAD PUMP EMERGENTLY. IT WAS NOTED THAT THROMBUS WAS SEEN IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63777 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 115862

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention