BEUDAMED
    FDA Adverse Event Other Summary report: N

    VENTAK PRISM 2DR

    MDR report key: 633493 · Received August 23, 2005

    Report

    Report Number
    633493
    Event Type
    Other
    Date Received
    August 23, 2005
    Date of Event
    August 18, 2005
    Report Date
    August 23, 2005
    Manufacturer
    GUIDANT CORPORATION
    Product Code
    LWS
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS RECALLED. DECISION TO REPLACE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRISM 2DR ICD LWS GUIDANT CORPORATION 1861 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR