BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUNCTIONAL ANESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM

    MDR report key: 697795 · Received March 9, 2006

    Report

    Report Number
    2953769-2006-00023
    Event Type
    Malfunction
    Date Received
    March 9, 2006
    Date of Event
    March 9, 2006
    Report Date
    March 9, 2006
    Manufacturer
    KYPHON, INC.
    Product Code
    BSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PATIENT WITH BACK PAIN UNDERWENT A 3-LEVEL PROVOCATIVE DISCOGRAPHY (PD) AND FUNCTIONAL ANETHETIC DISCOGRAPHY (FAD). ON X-RAY, THE GUIDEWIRE EXTENDED BEYOND THE CATHETER AND WAS NOTED TO BE LOOPED IN THE DISC. WHEN THE TREATING PHYSICIAN TRIED TO PULL THE GUIDEWIRE, HE ENCOUNTERED RESISTANCE. THE PHYSICIAN THEN REMOVED ALL DEVICES SIMULTANEOUSLY. REMOVAL OCCURRED WITHOUT MUCH RESISTANCE. A REPEAT X-RAY SHOWED A LINEAR DENSITY IN THE DISC CONSISTENT WITH A GUIDEWIRE. THE FAD WAS DISCONTINUED. A CT SCAN PERFORMED AFTER DISCONTINUATION OF THE FAD ALSO SHOWED A LINEAR DENSITY IN THE DISC CONSISTENT WITH A PIECE OF THE GUIDEWIRE. THE TREATING PHYSICIAN SAW THE PATIENT IN FOLLOW-UP; THE PATIENT REPORTED NO NEW SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUNCTIONAL ANESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM FUNCTIONAL ANESTHESIC DISCOGRAPHY (FAD) AND GUIDE WIRE ASSEM BSP KYPHON, INC. NA J6013102

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other