Implantable Systems Performance Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00959296

Acronym

ISPR

Enrollment

10981

Registered

2009-08-14

Start date

2003-08-31

Completion date

2016-09-27

Last updated

2017-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Brain Stimulation, Drug Infusion (Implantable Pumps), Sacral Neuromodulation, Spinal Cord Stimulation

Keywords

Registry, Pain, Chronic Pain, Back Pain, Intractable Spasticity, Parkinson's Disease, Essential Tremor, Dystonia, Implantable Pumps, Incontinence

Brief summary

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.

Interventions

DEVICEVarious

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Scheduled for an implant or replacement with a market-released Medtronic implantable drug pump, spinal cord stimulator, deep brain stimulator, or sacral nerve stimulator

Exclusion criteria

* Patient who is or will be inaccessible for follow-up at an ISPR study site * Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study

Design outcomes

Primary

Measure	Time frame	Description
Product Performance	Annually	To quantify and compare the rates of device-related events for market-released Medtronic Neuromodulation infusion and stimulation devices

Countries

Austria, France, Germany, Italy, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026