BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER, EU

    MDR report key: 2110936 · Received April 20, 2011

    Report

    Report Number
    2916596-2011-00158
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. APPROXIMATELY 2.5 YEARS POST-IMPLANT, THE PT REPORTED A RED HEART ALARM AND PUMP STOPPAGE WHILE HE WAS SITTING. THE ALARM DISAPPEARED AND THE PUMP RESTARTED, SO NO ACTION WAS TAKEN. THE PT WENT TO THE HOSPITAL AND THE SYSTEM CONTROLLER WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER, EU LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 103692 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other