BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3476989 · Received November 6, 2013

    Report

    Report Number
    2916596-2013-01412
    Event Type
    Injury
    Date Received
    November 6, 2013
    Date of Event
    October 8, 2013
    Report Date
    October 10, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE LVAD WAS RETURNED TO THE MFR FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013 WITH EVIDENCE OF HEMOLYSIS ON LABS. HE WAS TREATED WITH MEDICATION AND HIS LEVELS DECREASED. HIS LEVELS ROSE AGAIN AND THE HOSPITAL TRIED ANOTHER MEDICATION, BUT HIS LEVELS ROSE RAPIDLY, REQUIRING RE-INITIATION OF I.V. THERAPY. THE PATIENT RECEIVED A PUMP EXCHANGE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573499 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 109243

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention