Medtronic PSR TDD PMCF

Medtronic

Status: Completed

Conditions: Spasticity, Muscle; Chronic Pain

Study type: Observational

Funder types: Industry

Identifiers

NCT04714385

Medtronic PSR TDD PMCF

Details and patient eligibility

About

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.

Full description

This study was originally posted under NCT01524276 and now posted alone to adapt to new ISO regulation.

Enrollment: 209 patients

Sex: All

Volunteers: No Healthy Volunteers

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 exclusion criteria required by local law
• Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
• There is no indication at enrollment (e.g., medical conditions, anticipated relocation, etc.) that the patient will be unable to complete 48 months of follow-up after implant