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Medtronic Product Surveillance Registry (PSR)
Description
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.
Learn more at clinicaltrials.gov
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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