BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3961673 · Received June 17, 2014

    Report

    Report Number
    2916596-2014-01141
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 20, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE MANUFACTURER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION AS TO THE STATUS OF THE PATIENT. 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 BY THE VAD COORDINATOR THAT THE PATIENT EXPERIENCED UPPER AND LOWER GI BLEED AND WAS HOSPITALIZED FOR 10 DAYS. TREATMENT COURSE WAS 2 UNITS OF PACKED RED BLOOD CELLS (PRBC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355972 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 118144

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention