BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4962709 · Received August 4, 2015

    Report

    Report Number
    2916596-2015-01410
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    May 15, 2015
    Report Date
    July 7, 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

    APPROXIMATE AGE OF DEVICE - 2 YEARS AND 7 MONTHS. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED GASTROINTESTINAL BLEEDING COULD NOT BE CONCLUSIVELY DETERMINED. BLEEDING IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE PATIENT REMAINS ON VAD SUPPORT. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A HEMOGLOBIN LEVEL OF 6.4 G/DL. THEIR INR WAS 2.5. THE PATIENT WAS GIVEN 6 UNITS OF PACKED RED BLOOD CELLS. THE BLEEDING RESOLVED AND THE PATIENT WAS DISCHARGED AFTER 5 DAYS IN THE HOSPITAL. IT WAS REPORTED THAT THE VAD PARAMETERS REMAINED WITHIN NORMAL LIMITS THROUGHOUT THE EVENT AND THE PUMP FUNCTIONED AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507066 HEARTMATE II LVAS LEFT VENTRICULAR ASSIT DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R