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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.
This study was originally posted under NCT01524276 and now posted alone to adapt to new ISO regulation.
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| Measure | Description | Time Frame |
|---|---|---|
| Pump accuracy | 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. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pump survival | Demonstrate pump survival (freedom from product performance events) is > 90 percent at 4 years post-pump implant | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients implanted with SynchroMed II Model 8637 Programmable Pump who meet approved indications (Chronic pain and severe spasticity)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brugge | Bruges | Belgium | ||||
| Leuven |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Leuven |
| Belgium |
| Roeselare | Roeselare | Belgium |
| Sint-Niklaas | Sint-Niklaas | Belgium |
| Wilrijk | Wilrijk | Belgium |
| Praha | Prague | Czechia |
| Marseille | Marseille | France |
| Enschede | Enschede | Netherlands |
| Maastricht | Maastricht | Netherlands |
| Ljubljana | Ljubljana | Slovenia |
| Badalona | Badalona | Spain |
| Madrid | Madrid | Spain |
| Morges | Morges | Switzerland |
| Nottwil | Nottwil | Switzerland |
| Middlesbrough | Middlesbrough | United Kingdom |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009422 | Nervous System Diseases |