BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4142689 · Received October 2, 2014

    Report

    Report Number
    2916596-2014-01736
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    August 11, 2014
    Report Date
    September 3, 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 MFR WAS UNABLE TO CONDUCT AN INVESTIGATION AS THE PT REMAINS IMPLANTED WITH THE DEVICE. NO FURTHER ISSUES HAVE BEEN REPORTED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. BASED ON THE INFO AVAILABLE AND DUE TO THE DEVICE NOT BEING RETURNED FOR ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) IT WAS DISCOVERED THAT A SINGLE ANGIECTASIA WITH BLEEDING WAS FOUND IN THE PROXIMAL JEJUNUM. THE BLEEDING WAS TREATED WITH COAGULATION THERAPY AND THE PT WAS TRANSFUSED WITH ONE UNIT OF PACKED RED BLOOD CELLS. THE ANEMIA RESOLVED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614837 HEARTMATE II LVAS DSQ THORATEC CORP. 104911 119460

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention