BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3912779 · Received June 13, 2014

    Report

    Report Number
    2916596-2014-00974
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 14, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT HAD GI BLEED AFTER INITIAL DISCHARGE. MEDICAL MANAGEMENT. ASA DISCONTINUED. ADDITIONAL INFORMATION RECEIVED (B)(4) 2014: TWO MORE ADMISSIONS SINCE THE INITIAL INCIDENT FOR CONTINUED GI BLEEDING. OFF OF ASA THERAPY, INR GOAL DECREASED TO 1.5-2. CONTINUE WITH GI CONSULTS AND MEDICAL MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348987 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 106015 138087

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention