CLINICAL OUTCOMES Intrathecal Baclofen Therapy with Intrathecal (baclofen injection)

Brief Statement

See the device manual for detailed information regarding the Instructions For Use, the implant procedure, indications, contraindications, warnings, precautions and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at http://www.medtronic.eu/

For applicable products, consult instructions for use on http://www.medtronic.com/manuals. Manuals can be viewed using a current version of any major Internet browser. For best results, use Adobe Acrobat Reader® with the browser.

If you have any questions specific to the medicinal product that you are using this device to administer, please contact the Marketing Authorisation Holder.

When ITB is mentioned, we are considering Intrathecal baclofen (an anti-spastic) administered by an intrathecal drug delivery pump therapy. Medtronic provides only the intrathecal drug delivery pump and the catheter; the intrathecal baclofen is provided by an external company.