BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX DISCYPHOR CATHETER SYSTEM

    MDR report key: 1834526 · Received September 10, 2010

    Report

    Report Number
    2953769-2010-00389
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    GAA
    PMA / PMN Number
    K073516
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - DEVICE NOT RETURNED; FOLLOWED UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) PROCEDURE AT LEVELS L2/3, 3/4 AND 4/5. UPON REMOVAL OF THE L3/4 CATHETER, IT APPEARED TO BE STUCK IN THE PT AND WAS DIFFICULT TO REMOVE. THE BALLOON WAS DEFLATED AND NEEDLE HOLDERS WERE USED TO FORCEFULLY PULL THE CATHETER OUT. THE PHYSICIAN WAS NOT ABLE TO CONFIRM IF ANY FRAGMENTS OF THE BALLOON REMAINED IN THE PT. THE PHYSICIAN NOTED THAT A FUSION WILL TAKE PLACE AT THAT LEVEL. THE PT WAS REPORTEDLY DOING FINE POST PROCEDURE. NO ADDITIONAL INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX DISCYPHOR CATHETER SYSTEM FUNCTIONAL ANAESTHETIC DISCOGRAPHY GAA MEDTRONIC SPINE LLC D01E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK