BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2924976 · Received January 17, 2013

    Report

    Report Number
    2916596-2013-00047
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE NURSING STAFF THAT DURING THE REVIEW OF THE SYSTEM CONTROLLER HISTORY LOG, A PUMP STOPPAGE, FOLLOWED BY A SYSTEM CONTROLLER CELL ALARM WAS SEEN HOWEVER, NO ALARMS WERE DISPLAYED FROM THE SYSTEM CONTROLLER DURING THIS TIME. THE LOG FILE CONFIRMS THAT ALARMS WERE RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25955 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 103696 111509

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening