BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2800398 · Received October 16, 2012

    Report

    Report Number
    2916596-2012-00987
    Event Type
    Death
    Date Received
    October 16, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INTO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PT¿S WIFE REPORTED THAT SHE FOUND THE PT IN THE BATHROOM, BLUE AND SLUMPED OVER THE WALKER. THE PT¿S WIFE ADMINISTERED CARDIOPULMONARY RESUSCITATION (CPR) AND CALLED 911. CPR WAS CONTINUED BY EMERGENCY MEDICAL SERVICES (EMS). UPON THE PT¿S ARRIVAL TO THE HOSPITAL, AN ECHOCARDIOGRAM (ECHO) WAS PERFORMED AND THE CARDIOLOGIST STATED THAT THERE WAS MINIMAL ELECTRICAL ACTIVITY OR HEART MOVEMENT. ALL PUMP PARAMETERS WERE WITHIN NORMAL LIMITS AND NO PUMP ALARMS WERE NOTED. FAMILY DECIDED TO STOP PUMP AND PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 116101

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death