BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4100741 · Received September 12, 2014

    Report

    Report Number
    2916596-2014-01607
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 SURGEON THAT THE PATIENT HAD A HISTORY OF GASTROINTESTINAL (GI) BLEEDING. THE PATIENT IN RECOVERY WITH AN EJECTION FRACTION (EF) OF 45 PERCENT AND IS DOING WELL OTHER THAN OCCASIONAL GI BLEEDING. THE PATIENT WAS EXPLANTED OFF THE PUMP FOR RECOVER, VIA A SUBCOSTAL APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565111 HEARTMATE II LVAS DSQ:LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 112487

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention