BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2872053 · Received December 11, 2012

    Report

    Report Number
    2916596-2012-01155
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 12, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT WAS HOME WHEN THE SYSTEM CONTROLLER BEGAN ALARMING WITH RED HEART ALARMS WHILE CONNECTED TO BATTERIES. THE PT ESTIMATED THAT THERE WAS LOW FLOW OF APPROXIMATELY 100 MINUTES. THE PT EXCHANGED TO THE BACKUP SYSTEM CONTROLLER AND THEN WAS READMITTED TO THE HOSPITAL. THE SYSTEM CONTROLLER "FROZE" AND COULD NOT BE INTERROGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103696 115622

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other