BEUDAMED
    FDA Adverse Event Other Summary report: N

    VENTAK PRIZM 2DR

    MDR report key: 620514 · Received July 5, 2005

    Report

    Report Number
    620514
    Event Type
    Other
    Date Received
    July 5, 2005
    Date of Event
    June 27, 2005
    Report Date
    July 5, 2005
    Manufacturer
    GUIDANT CORP.
    Product Code
    LWS
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FDA RECALL OF ICD. DEVICE REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR