BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVACOR N100 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 1358746 · Received April 7, 2009

    Report

    Report Number
    2916284-2009-00001
    Event Type
    Other
    Date Received
    April 7, 2009
    Date of Event
    January 30, 2009
    Report Date
    March 11, 2009
    Manufacturer
    WORLD HEART, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE NOVACOR LVAS PUMP DRIVE UNIT WAS EXPLANTED DUE TO INFECTION AND REPLACED WITH A HEARTMATE II. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHIN ONE WEEK OF THE SURGERY. THE EXPLANTED DEVICE IS BELIEVED TO HAVE BEEN DISPOSED OF AND WILL NOT BE RETURNED TO WORLDHEART. THEREFORE, ENGINEERING ANALYSIS OF THE PUMP IS NOT POSSIBLE, NOR NECESSARY AS THERE WAS NO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVACOR N100 LEFT VENTRICULAR ASSIST SYSTEM PUMP/DRIVE UNIT DSQ WORLD HEART, INC. 0505051786

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention