BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4522179 · Received February 18, 2015

    Report

    Report Number
    2916596-2015-00298
    Event Type
    Injury
    Date Received
    February 18, 2015
    Date of Event
    December 10, 2014
    Report Date
    January 21, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE FOR THE PATIENT¿S GI BLEED COULD NOT BE DETERMINED THROUGH THIS EVALUATION. THE ACCOUNT COMMUNICATED THAT THE PATIENT WAS ADMITTED WITH DARK BLOODY STOOL AS WELL AS AN INTERNATIONAL NORMALIZED RATIO (INR) OF 4.2. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED AND THE PATIENT WAS TREATED WITH A 3 UNIT TRANSFUSION OF PACKED RED BLOOD CELLS. IT WAS FURTHER COMMUNICATED THAT THE PATIENT¿S PUMP WAS FUNCTIONING AS INTENDED. THE PATIENT WAS ULTIMATELY DISCHARGED ON (B)(6) 2014. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT WEIGHT WAS NOT AVAILABLE. APPROXIMATE AGE OF DEVICE - 11 MONTHS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH DARK BLOODY STOOL. THE PATIENT'S INTERNATIONAL NORMALIZED RATIO VALUE WAS 4.2. THE PATIENT WAS DIAGNOSED WITH GI BLEEDING. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED; HOWEVER, THE RESULTS WERE NOT PROVIDED. THE PATIENT WAS TRANSFUSED WITH THREE UNITS OF PACKED RED BLOOD CELLS AND WAS DISCHARGED FROM THE HOSPITAL. THE LVAD WAS REPORTED TO BE FUNCTIONING AS INTENDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117092 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention