BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3111287 · Received May 9, 2013

    Report

    Report Number
    2916596-2013-00499
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 11, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE LVAD 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 MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PATIENT CAME IN AND WAS NOTED TO BE UNDERSUPPORTED. THE PATIENT WAS ADMINISTERED MEDICATION AFTER THE PATIENT STARTED TO SHOW SIGNS OF HEMOLYSIS WITH AN INCREASED PLASMA FREE HGB. A PUMP INFLOW OR OUTFLOW OBSTRUCTION WAS SUSPECTED. THE PATIENT'S PUMP WAS EXCHANGED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204934 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 117874

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention NA.