BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3950521 · Received July 11, 2014

    Report

    Report Number
    2916596-2014-01115
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 13, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD ENGINEER THAT THE PATIENT WAS EXPERIENCING HIGH LACTATE DEHYDROGENASE VALUES AND THE DEVICE DID NOT SEEM TO SUPPORT THE PATIENT. A PUMP EXCHANGE FROM ONE LVAD TO ANOTHER LVAD WAS PERFORMED DUE TO HIGH CONFIRMED LAB VALUES INDICATING HEMOLYSIS AND LACK OF SUPPORT FROM THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406887 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 108896

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention