BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2772221 · Received October 2, 2012

    Report

    Report Number
    2916596-2012-00935
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 4, 2012
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. 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 VAD COORDINATOR THAT THE HOSP SUSPECTS THROMBUS OR A DEVICE MALFUNCTION. THE PRIMARY SYSTEM CONTROLLER WAS REPLACED AND NO CHANGE WAS NOTED IN THE LVAD PARAMETERS OR THE PT'S VITAL SIGNS. THE RECORDED LVAD SYSTEM POWER READINGS CONTINUED TO BE ABOVE 10 WATTS ON THE NEW SYSTEM CONTROLLER. AN ECHOCARDIOGRAM (ECHO) AND LAB WORK WERE PERFORMED AND BOTH APPEARED NORMAL. THE LOG FILE WAS REVIEWED AND ELEVATIONS IN POWER AND ONE INSTANCE OF A PUMP STOPPAGE WERE REPORTED. IT WAS REPORTED THAT THE PT IS CURRENTLY RUNNING ON BATTERY POWER AND THAT THE PERCUTANEOUS LEAD WAS INSPECTED AND NO PROBLEMS WERE FOUND. IT WAS ALSO REPORTED THAT AN X-RAY OF THE INTERNAL PORTION OF THE PERCUTANEOUS LEAD WILL BE TAKEN. THE MFR HAS BEEN UNABLE TO OBTAIN THE VAD SERIAL NUMBER AT THIS TIME FROM THE HOSP. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP 104911

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening