BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER, EU

    MDR report key: 2092933 · Received April 11, 2011

    Report

    Report Number
    2916596-2011-00145
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON LVAD SUPPORT. THE DEVICE WAS RETURNED TO THE MFR FOR EVAL 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. APPROX 1 YEAR POST-IMPLANT, THE PT REPORTED A RED HEART ALARM AND PUMP STOPPAGE WHILE HE WAS SLEEPING AND CONNECTED TO THE POWER MODULE. THE ALARM DISAPPEARED AND THE PUMP RESTARTED, SO NO ACTION WAS TAKEN. THE NEXT MORNING, 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 CORP. 103692 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other