BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6661001 · Received June 22, 2017

    Report

    Report Number
    2916596-2017-01297
    Event Type
    Death
    Date Received
    June 22, 2017
    Date of Event
    May 24, 2017
    Report Date
    November 9, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE UNIQUE IDENTIFIER (UDI)# (B)(4). APPROXIMATE AGE OF DEVICE - 1 YEAR, 8 MONTHS. NO ADDITIONAL INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. 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) 2015. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT HAD DISCONNECTED THE LVAD PRIOR TO DEATH. THE SPOUSE HAD CALLED THE IMPLANTING CENTER AROUND 11:30 PM PDT TO SPEAK WITH THE LVAD CLINICIAN AND EXPLAINED THAT SHE HAD COME HOME TO FIND THE PATIENT DOWN AND THE DEVICE DISCONNECTED. THE SPOUSE WAS INSTRUCTED BY THE LVAD CLINICIAN IN RECONNECTING THE DRIVELINE, AND 911 WAS CALLED. THE PATIENT WAS PRONOUNCED DEAD BY EMERGENCY SERVICES (EMS). THE LVAD CLINICIAN INSTRUCTED THE EMS TEAM MEMBER IN REMOVING THE SYSTEM CONTROLLER. THE PATIENT HAD NOT BEEN CERTIFIED BY THE IMPLANTING CENTER TO BE ALONE, AND THE SPOUSE HAD BEEN THE DESIGNATED CAREGIVER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440159 HEARTMATE II LVAS LEFT VENTIRULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death