BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1930166 · Received November 22, 2010

    Report

    Report Number
    2916596-2010-00309
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT WHILE DOWNLOADING THE SYSTEM CONTROLLER LOG FILE, SHE NOTED THAT A RED HEART ALARM FOR LOW FLOW FOLLOWED BY PUMP STOP WAS RECORDED APPROXIMATELY 1.5 WEEKS PRIOR. THE PATIENT HAD NOT NOTICED ANY ISSUE WITH THE PERFORMANCE OF THE PUMP. THE SYSTEM CONTROLLER WAS EXCHANGED WITHOUT INCIDENT. THE PT REMAINS ONGOING ON THE LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other