BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1993839 · Received January 13, 2011

    Report

    Report Number
    2916596-2011-00020
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT WHEN THE PT WAS SWITCHED FROM THE POWER BASE UNIT (PBU) TO THE 14 VOLT LITHIUM ION BATTERIES THE PT'S SYSTEM CONTROLLER ALARMED. THE PT REPORTED THAT SHE FELT HEAVINESS ON HER CHEST AND "DID NOT FEEL WELL". PER ADDITIONAL INFO, THE PUMP STOPPED. THE BATTERIES WERE THEN EXCHANGED WITH 12 VOLT SEALED LEADED ACID BATTERIES; HOWEVER, THE PUMP DID NOT RESTART. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE PT WAS PLACED BACK ON THE PBU AND THE PUMP RESTARTED. THE PT WAS THEN SWITCHED OVER TO THE NEW PERIPHERALS WITHOUT INCIDENT. THE PT REMAINS ONGOING WITH NO FURTHER ISSUES.

    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 44 YR Required Intervention