BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3950520 · Received July 11, 2014

    Report

    Report Number
    2916596-2014-01136
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 THAT THE PATIENT HAD A PUMP EXCHANGE DUE TO HEMOLYSIS AND SUSPECTED DEVICE THROMBOSIS. ADDITIONAL INFORMATION PROVIDED TO THE MANUFACTURER INDICATED THAT THE PATIENT HAD ELEVATED LACTATE DEHYDROGENASE (LDH) LEVELS. PUMP PARAMETERS WERE UNCHANGED AND THERE WERE REPORTEDLY NO CLINICAL INDICATORS THAT WOULD HAVE PREDISPOSED THE PATIENT TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406779 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 140797

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention