BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1730098 · Received June 17, 2010

    Report

    Report Number
    2916596-2010-00142
    Event Type
    Other
    Date Received
    June 17, 2010
    Date of Event
    May 16, 2010
    Report Date
    May 19, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 THE PT CALLED AND STATED THAT HIS SYSTEM CONTROLLER WAS IN BACKUP MODE. THE PT WENT TO THE HOSPITAL AND THE SYSTEM CONTROLLER WAS EXCHANGED. THE LOG FILE WAS REVIEWED AND INDICATED THAT THE CONTROLLER WAS IN POWER SAVER MODE AND THEN LOST POWER. PER ADDITIONAL INFO, THE LOSS OF POWER APPEARED TO BE DUE TO THE PT "LETTING THE BATTERIES RUN DOWN." THE PT REMAINS ONGOING ON THE LVAD AND NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 103696 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other