BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4223721 · Received October 31, 2014

    Report

    Report Number
    2916596-2014-01994
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    August 15, 2014
    Report Date
    October 2, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED TO THE MFR FOR EVALUATION AS IT REMAINS IN USE SUPPORTING THE PT. A ROOT CAUSE FOR THE REPORT OF THE GI BLEEDING COULD NOT BE DETERMINED THROUGH THIS EVALUATION. IT WAS REPORTED THAT THE PT IS DOING WELL AT HOME. NO FURTHER ISSUES HAVE BEEN REPORTED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. 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 BY THE VAD COORDINATOR THAT THE PT WAS ADMITTED INTO THE HOSP FOR A GI BLEED ON (B)(6) 2014. AN UPPER GI ENDOSCOPY WAS PERFORMED AND THE SOURCE OF BLEEDING WAS NOT FOUND. THE PT WAS TRANSFUSED WITH THREE UNITS OF BLOOD, AND THE BLEEDING WAS RESOLVED. THE PT WAS DISCHARGED TO HOME ON (B)(6) 2014, AND IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698219 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 140535

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention