BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3240156 · Received July 18, 2013

    Report

    Report Number
    2916596-2013-00904
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 21, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT WAS READMITTED FOR GASTROINTESTINAL BLEEDING (GIB) WITH DARK STOOLS, AND INTERNATIONAL NORMALIZED RATIO (INR) OF 2.9. THE PT'S PUMP SPEED WAS DECREASED AND FURTHER TESTING IS BEING DONE. THE HOSPITAL IS MONITORING THE PT'S STOOLS, HEMOGLOBIN AND HEMATOCRIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334385 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 115778

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention