BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2431023 · Received January 26, 2012

    Report

    Report Number
    2916596-2012-00052
    Event Type
    Injury
    Date Received
    January 26, 2012
    Date of Event
    December 29, 2011
    Report Date
    December 29, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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 PERFUSIONIST THAT THE PT WAS PRESENTED WITH HIGH LACTATE DEHYDROGENASE (LDH) AND UNABLE TO MAINTAIN PUMP SPEED. SOME PUMP SPEED VARIATION WAS ALSO NOTED. ALL OTHER PARAMETERS APPEARED NORMAL AND PT NOT SYMPTOMATIC. AN ECHOCARDIOGRAM CONFIRMED NORMAL INFLOW AND OUTFLOW VELOCITIES WITH NO EVIDENCE OF CANNULA OBSTRUCTION. THE SYSTEM LOG FILES WERE REVIEWED BY THE MFR AND REVEALED NO ABNORMALITIES WITH REGARD TO PUMP FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 106686

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention