BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2843371 · Received November 19, 2012

    Report

    Report Number
    2916596-2012-01118
    Event Type
    Death
    Date Received
    November 19, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 25, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT AFTER 1.5 MONTH OF SUPPORT, THE PATIENT EXPIRED DUE TO SEPTIC SHOCK. NO OTHER INFORMATION REGARDING THE PATIENT DEATH WAS PROVIDED TO THE MANUFACTURER; HOWEVER, AN ANALYSIS OF THE EXPLANTED PUMP WAS REQUESTED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 115175

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death