BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPINECATH INTRADISCAL CATHETER

    MDR report key: 291419 · Received August 15, 2000

    Report

    Report Number
    2953127-2000-00014
    Event Type
    Other
    Date Received
    August 15, 2000
    Date of Event
    July 13, 2000
    Report Date
    August 11, 2000
    Manufacturer
    ORATEC INTERVENTIONS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DISTAL PORTION OF DEVICE BROKE OFF IN PT'S DISC. THE CATHETER WAS NOT HEATED. FRAGMENT REMAINS IN THE DISC. IT IS UNKNOWN AT THIS TIME WHETHER ANY CLINICAL SEQUELAE HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINECATH INTRADISCAL CATHETER ELECTROTHERMAL INTRADISCAL CATHETER GEI ORATEC INTERVENTIONS, INC. 902002 042400-18

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other