BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3760787 · Received April 7, 2014

    Report

    Report Number
    2916596-2014-00522
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 LEFT VENTRICULAR ASSIST DEVICE. THE SURGEON REPORTED THAT THE PUMP PARAMETERS CHANGED, FLOWS FLUCTUATED AND POWER INCREASED. THE PUMP'S SPEED WAS DECREASED AND PI IMPROVED, BUT FLOWS CONTINUED TO FLUCTUATE. THE SURGEON WANTED TO SEND THE PT TO REHAB, BUT HE WAS CONCERNED ABOUT SUSPECTED PUMP THROMBUS. THE PT HAD HIGH LACTATE DEHYDROGENASE, CI 2.1, CT SCAN WAS OK, AND INFLOW AND OUTFLOW WERE OK. MILD AL AND SOME RIGHT HEART FAILURE, MEAN BP 70-80. THE SURGEON ALSO FELT THAT HE HEARD A HIGHER PITCH PUMP SOUND. THE PT WAS USING A POCKET SYSTEM CONTROLLER. THE SURGEON REQUESTED AN EPC SYSTEM CONTROLLER AND MAY POSSIBLY TAKE THE PT TO THE OPERATING ROOM TO EVALUATE FOR PUMP THROMBUS. THE POCKET SYSTEM CONTROLLER WAS EXCHANGED TO THE BACK UP POCKET SYSTEM CONTROLLER AND THE FLOWS STABILIZED. THEY ARE PLANNING TO TAKE THE PT TO THE CATH LAB FOR AN AV NODE ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205702 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 135481

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention