BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3221451 · Received July 9, 2013

    Report

    Report Number
    2916596-2013-00875
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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 PT DISCONNECTED BOTH POWER LEADS FROM THE SYS CONTROLLER. THE SYS CONTROLLER CELL BATTERY WAS ACTIVATED. THE SYS MONITOR HISTORY SCREEN INDICATED LOW FLOW ALARMS AND A CLOCK RESET. LOG FILES REVIEWED BY THE MFR CONFIRMED RED HEART ALARM EVENTS FOUND AS A RESULT OF POWER BEING DISCONNECTED FROM THE SYS CONTROLLER. WHEN POWER WAS RESTORED, NO OTHER EVENTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313610 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 118141

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention