BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 4962708 · Received August 4, 2015

    Report

    Report Number
    2916596-2015-01409
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    May 11, 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 - 3 YEARS AND 2.5 MONTHS. A FULL EXAMINATION OF THE HEARTMATE II LVAS COULD NOT BE CONDUCTED AS THE PATIENT REMAINS ONGOING ON VAD SUPPORT. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENT NOT BE CONCLUSIVELY DETERMINED. 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 PATIENT EXPERIENCED ANEMIA AND SUSPECTED BUT UNCONFIRMED GASTROINTESTINAL BLEEDING. THE PATIENT WAS GIVEN 2 UNITS OF PACKED RED BLOOD CELLS. THE PATIENT'S BLEEDING THEN STABILIZED AND THE PATIENT WAS DISCHARGED. IT WAS REPORTED THAT THE PUMP FUNCTIONED AS DESIGNED THROUGHOUT THE EVENT. INCIDENTALLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL AT THE TIME DUE TO SYMPTOMS OF HEART FAILURE AND WAS TREATED WITH DIURETIC THERAPY. THE PATIENT REPORTEDLY HAD SYMPTOMS OF WEAKNESS, FLUID OVERLOAD, AND WEIGHT GAIN. THE SYMPTOMS WERE BELIEVED TO BE RELATED TO RIGHT HEART FAILURE ONLY AS THE PUMP WAS SUPPORTING THE LEFT SIDE AND APPEARED TO BE FUNCTIONING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506512 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R