BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6080767 · Received November 4, 2016

    Report

    Report Number
    2916596-2016-02152
    Event Type
    Death
    Date Received
    November 4, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 11, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 2 YEARS AND 9 MONTHS. THE PUMP WAS NOT RETURNED FOR EVALUATION AS IT WAS NOT EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT EXPLANTED AND THEREFORE NOT AVAILABLE FOR INVESTIGATION. A CORRELATION BETWEEN THE DEVICE AND PATIENT¿S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO HEART FAILURE AND THE HOSPITAL STAFF DID NOT BELIEVE THE PATIENT¿S DEATH WAS RELATED TO THE PUMP. 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) ON (B)(6) 2013. IT REPORTED THAT ON (B)(6) 2016, THE PATIENT WENT INTO THE HOSPITAL AND DECOMPENSATED QUICKLY, AND EXPIRED DUE TO HEART FAILURE. THE HEALTH PROFESSIONALS DID NOT FEEL THE PATIENT'S DEATH WAS RELATED TO THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729791 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 106015

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death