BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2447776 · Received February 9, 2012

    Report

    Report Number
    2916596-2012-00126
    Event Type
    Death
    Date Received
    February 9, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 COORDINATOR THAT THE PATIENT HAD SYMPTOMS OF HEMOLYSIS WITH POWER SPIKES. THE LEFT VENTRICULAR DIAMETER WAS UNCHANGED WITH SPEED INCREASE AND AORTIC VALVE WAS OPENING EVERY BEAT FOR THE PAST FEW WEEKS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HYPOXIC EPISODE AND HAD A DROP IN BLOOD PRESSURE. THE PATIENT BECAME UNRESPONSIVE AND UNFORTUNATELY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 102731

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Death