BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCYPHOR CATHETER SYSTEM

    MDR report key: 1061437 · Received June 17, 2008

    Report

    Report Number
    2953769-2008-00018
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    April 1, 2008
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    BSP
    PMA / PMN Number
    K043500
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - OTHER; FOLLOW UP CONVERSATION WITH COMPANY REPRESENTATIVE REPORTING THE EVENT. RESULTS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A PT UNDERWENT AN F.A.D PROCEDURE. APPROXIMATELY ONE MONTH AFTER THE PROCEDURE, THE PT COMPLAINED OF LEG PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCYPHOR CATHETER SYSTEM F.A.D. CATHETER SYSTEM BSP MEDTRONIC SPINE LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other