Long-term Surveillance of the MedStream Programmable Infusion System

Inclusion Criteria: * The subject is a viable candidate for "de novo" or continued (pump replacement) therapy for the treatment of severe spasticity with intrathecal Baclofen delivered by an implantable programmable pump. * The subject or his/her Legally Authorized Representative must voluntarily provide Informed Consent for participation in this study in accordance with 21 Code of Federal Regulations (CFR) Part 50. * The subject is willing to comply with the protocol-specified follow-up visit requirements for a period of 36 months after implant. * The subject has an anticipated life expectancy of 24 months or greater. * The subject must be 18 years of age or older at time of MedStream implant procedure. * The subject is of sufficient body size to accommodate pump placement, in the opinion of the Investigator. * The subject will receive a de novo or replacement implant of the MedStream 20 mL or 40 mL pump, MedStream approved catheter(s) and MedStream accessories. * The Investigator intends to use Baclofen in the pump for treatment of severe spasticity * The subject is capable of self-reporting spasm frequency. Exclusion Criteria: * Concurrent enrollment in an investigational device or drug study that has not completed the required follow-up period. * Subject has had an infection and/or inflammation at or near the pump and/or catheter implantation site(s) within 30 days preceding enrollment. * Evidence of a fever or infection within 10 days prior to the surgical implant pro…