BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4223232 · Received October 27, 2014

    Report

    Report Number
    2916596-2014-01975
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 29, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT CONTINUES ON LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED. 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 (LVAD). IT WAS REPORTED THAT THE PATIENT WAS ADMITTED DUE TO A GI BLEED. NO ALARMS WERE REPORTED FOR THE EVENT. THE PATIENT RECEIVED 2 UNITS OF PACKED RED BLOOD CELLS (PRBCS). THE VAD COORDINATOR STATES THE PUMP FUNCTIONED AS INTENDED DURING THE EVENT. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681089 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 117496

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention