BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3162468 · Received June 6, 2013

    Report

    Report Number
    2916596-2013-00718
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE VAD COORDINATOR REPORTED THAT WHILE ATTENDING A ROUTINE CLINIC VISIT IT WAS DETERMINED THAT A SPEED DECREASE WOULD BE MADE. THE BACK-UP SYSTEM CONTROLLER WOULD NOT PROGRAM UPON TETHERING TO THE POWER MODULE AND SYSTEM MONITOR. THE SYSTEM MONITOR DISPLAYED NORMAL ALARMS AND VISUALS BUT THERE WAS NO OPTION TO TOGGLE THROUGH THE SCREENS. THE CABLES WERE DISCONNECTED AND RECONNECTED SEVERAL TIMES. THE BACK-UP SYSTEM CONTROLLER WAS MANUALLY PLACED INTO "BACK-UP MODE". AT THAT POINT, THE SYSTEM CONTROLLER WAS THEN ABLE TO BE PROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251533 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 88279

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other