BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6199927 · Received December 22, 2016

    Report

    Report Number
    2916596-2016-02498
    Event Type
    Death
    Date Received
    December 22, 2016
    Date of Event
    November 25, 2016
    Report Date
    May 4, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CORRELATION BETWEEN THE DEVICE AND THE PATIENT'S EXPIRATION COULD NOT BE CONCLUSIVELY DETERMINED. THE PATIENT WAS FOUND DOWN AND UNRESPONSIVE AT HOME BY THEIR FAMILY. THE CENTER REPORTED THAT NO LOG FILES OR EQUIPMENT ARE AVAILABLE. NO AUTOPSY WAS PERFORMED AND THE PUMP WAS NOT EXPLANTED. NO PRODUCT IS AVAILABLE FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS MANUFACTURED PRIOR TO THE UDI LABELING IMPLEMENTATION. APPROXIMATE AGE OF DEVICE - 4 YEARS, 7 MONTHS. NO FURTHER INFORMATION IS AVAILABLE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT WAS FOUND UNRESPONSIVE BY FAMILY ON (B)(6) 2016. IT IS NOT KNOWN IF THE PUMP WAS RUNNING OR IF THERE WERE ALARMS AT THE TIME OF THE EVENT. THE VAD COORDINATOR STATED THAT AN AUTOPSY WAS NOT PERFORMED. NONE OF THE PATIENT¿S EQUIPMENT HAD BEEN RETURNED TO THE CENTER BY THE PATIENT'S FAMILY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851079 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death