BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 5994779 · Received October 3, 2016

    Report

    Report Number
    2916596-2016-01903
    Event Type
    Death
    Date Received
    October 3, 2016
    Date of Event
    March 11, 2016
    Report Date
    September 7, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO EQUIPMENT WAS RETURNED FOR EVALUATION. A DIRECT CORRELATION BETWEEN THE DEVICE AND THE PATIENT¿S OUTCOME COULD NOT BE DETERMINED. IT WAS REPORTED BY THE HOSPITAL PERSONNEL THAT THERE WERE NO DEVICE ISSUES, AND NO LOG FILES ARE AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 1 YEAR, 3 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). IT WAS REPORTED THAT THE PATIENT EXPIRED UNEXPECTEDLY AT HOME ON (B)(6) 2016. THE CAUSE OF EXPIRATION WAS UNDETERMINED. THE PATIENT HAD CALLED THE IMPLANTING CENTER 24 HOURS PRIOR TO REPORT NOT FEELING WELL, WITH COLD LIKE SYMPTOMS, BUT NO SERIOUS ISSUES WERE NOTED. THE PATIENT'S SPOUSE HAD WORKED NIGHT SHIFT AND REPORTED PATIENT HAD TAKEN SOME COUGH MEDICATION AND WAS ASLEEP ON THE COUCH. THE PATIENT'S SPOUSE AWOKE SEVERAL HOURS LATER AND WENT DOWNSTAIRS. THE PATIENT WAS FOUND FACE DOWN ON THE LIVING ROOM FLOOR WITH NO DOPPLER BLOOD PRESSURE OR PULSE. THE SYSTEM CONTROLLER WAS PRODUCING THE LOW FLOW ALARM. IT WAS REPORTED THAT THERE WERE NO DEVICE ISSUES AND THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646267 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death