BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6204926 · Received December 27, 2016

    Report

    Report Number
    2916596-2016-02519
    Event Type
    Death
    Date Received
    December 27, 2016
    Date of Event
    November 13, 2016
    Report Date
    June 12, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED DRIVELINE INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. DRIVELINE INFECTION 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. A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING THE STERILIZATION AND PACKAGING DOCUMENTATION, FOUND NO DEVIATIONS FROM MANUFACTURING SPECIFICATIONS. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED DRIVELINE INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. DRIVELINE INFECTION 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. A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING THE STERILIZATION AND PACKAGING DOCUMENTATION, FOUND NO DEVIATIONS FROM MANUFACTURING SPECIFICATIONS. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT. H3 OTHER TEXT: PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 5 YEARS AND 11 MONTHS. NO FURTHER INFORMATION WAS PROVIDED. 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) 2010. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2016 AFTER A LONG TERM DRIVELINE INFECTION THAT WAS PREVIOUSLY UNREPORTED. THE PATIENT WAS AT HOME UNDER HOSPICE CARE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856848 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death