Chronic Pain, Spasticity, Muscle
Conditions
Brief summary
The purpose of this study is to provide continuing evaluation and reporting of safety and performance of the SynchroMed II Infusion System within its intended use. Data will support post-market surveillance obligations.
Detailed description
This study was originally posted under NCT01524276 and now posted alone to adapt to new ISO regulation.
Interventions
None listed
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * Patient has or is intended to receive or be treated with an eligible Medtronic product * Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment * The indication for implant meets approved indications * The patient can reasonably be expected to remain fully on label for a 48-month time period after implant
Exclusion criteria
* Patient who is, or will be, inaccessible for follow-up * Patient with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pump accuracy | 4 years | Demonstrate that the proportion of subjects treated as intended (p) with flow rate accuracy outside the interval of 0.75 to 1.25 (±25 percent) is \< 10 percent with 95 percent confidence at 4 years post implant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pump survival | 4 years | Demonstrate pump survival (freedom from product performance events) is \> 90 percent at 4 years post-pump implant |
Countries
Belgium, Czechia, France, Netherlands, Slovenia, Spain, Switzerland, United Kingdom
Outcome results
None listed