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The Implantable Systems Performance Registry (ISPR) was developed to evaluate the long-term reliability and performance of market-released Medtronic Neuromodulation infusion and stimulation products.
Completion Notice: The ISPR was created by Medtronic to monitor the performance of commercially available products. This registry was initially designed to track performance of Medtronic's implantable infusion and spinal cord stimulation systems beginning in August 2003 and June 2004, respectively. Medtronic DBS Systems were added to the ISPR in June 2009, and Sacral Neuromodulation Systems in April 2010. Medtronic retired the ISPR in April 2016 and merged the data collected from this registry into the Product Surveillance Registry (PSR). Please refer to that record, Clinical Trials identifier: NCT01524276, for further information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with a device implant | Patients implanted and consented at a study center with a market-released Medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Various | Device | Patients implanted and consented at a study center with a market-released Medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator. |
| Measure | Description | Time Frame |
|---|---|---|
| Product Performance | To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices | Annually |
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Inclusion Criteria:
Exclusion Criteria:
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Primary Care Clinic
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| Name | Affiliation | Role |
|---|---|---|
| ISPR Team | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | United States | ||||
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| Scottsdale |
| Arizona |
| United States |
| Aliso Viejo | California | United States |
| Los Angeles | California | United States |
| Napa | California | United States |
| Palm Springs | California | United States |
| Pasadena | California | United States |
| San Diego | California | United States |
| Upland | California | United States |
| Washington D.C. | District of Columbia | United States |
| Site recruiting for sacral nerve stimulation | Bradenton | Florida | United States |
| Merritt Island | Florida | United States |
| Ocala | Florida | United States |
| Atlanta | Georgia | United States |
| Gainesville | Georgia | United States |
| Bloomington | Illinois | United States |
| Chicago | Illinois | United States |
| Evansville | Indiana | United States |
| Muncie | Indiana | United States |
| South Bend | Indiana | United States |
| Iowa City | Iowa | United States |
| West Des Moines | Iowa | United States |
| Annapolis | Maryland | United States |
| Silver Spring | Maryland | United States |
| Westminster | Maryland | United States |
| Minneapolis | Minnesota | United States |
| Saint Paul | Minnesota | United States |
| St Louis | Missouri | United States |
| Buffalo | New York | United States |
| Great Neck | New York | United States |
| New York | New York | United States |
| Poughkeepsie | New York | United States |
| Winston-Salem | North Carolina | United States |
| Site is recruiting for Deep Brain Stimulation | Cincinnati | Ohio | United States |
| West Chester | Ohio | United States |
| York | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Houston | Texas | United States |
| Tyler | Texas | United States |
| Salt Lake City | Utah | United States |
| Roanoke | Virginia | United States |
| Bremerton | Washington | United States |
| Seattle | Washington | United States |
| Vienna | Austria |
| Montpellier | France |
| Cologne | Germany |
| Hanover | Germany |
| Pavia | Italy |
| Barcelona | Spain |
| Oxford | United Kingdom |
| ID | Term |
|---|---|
| D010146 | Pain |
| D059350 | Chronic Pain |
| D001416 | Back Pain |
| D010300 | Parkinson Disease |
| D020329 | Essential Tremor |
| D004421 | Dystonia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020820 | Dyskinesias |
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