BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4941731 · Received July 27, 2015

    Report

    Report Number
    2916596-2015-01357
    Event Type
    Death
    Date Received
    July 27, 2015
    Date of Event
    October 1, 2014
    Report Date
    June 29, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 1 YEAR AND 4 MONTHS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS UNABLE TO CONDUCT AN INVESTIGATION OF THE DEVICE BECAUSE IT WAS NOT RETURNED BY THE HOSPITAL. A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE AND DUE TO THE DEVICE NOT BEING RETURNED FOR ANALYSIS, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS CONNECTED TO BATTERY POWER WHEN THE REPORTED STROKE TOOK PLACE AND THE PUMP WAS STILL OPERATING WITH NO ALARMS. IT WAS NOT KNOWN HOW LONG THE PATIENT HAD BEEN EXPIRED BEFORE BEING FOUND BUT THE FAMILY NOTED HE WAS COOL TO THE TOUCH.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2015. THE PATIENT WAS FOUND EXPIRED WHILE ON THE TOILET. THE CAUSE OF EXPIRATION WAS REPORTED TO POSSIBLY BE A STROKE. THE PATIENT'S FAMILY CHOSE NOT TO HAVE AN AUTOPSY PERFORMED. ALL LVAS EQUIPMENT WAS REPORTED TO HAVE BEEN FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486802 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death