BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER, EU

    MDR report key: 1961589 · Received December 27, 2010

    Report

    Report Number
    2916596-2010-00354
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 29, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR 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. APPROXIMATELY 3 MONTHS POST-IMPLANT, THE PATIENT WAS BEING TRAINED ON EXCHANGING THE SYSTEM CONTROLLER AND WHEN DOING SO, ONCE THE BACKUP SYSTEM CONTROLLER WAS CONNECTED, THE PUMP DID NOT START AUTOMATICALLY, AS EXPECTED. THE PRIMARY SYSTEM CONTROLLER WAS CONNECTED IMMEDIATELY AND THE BACKUP SYSTEM CONTROLLER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER, EU LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103692 93495

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other