Medtronic Product Surveillance Registry

Serve as an ongoing source of product performance, patient safety and clinical outcomes information associated with the use of market released products.

Inclusion Criteria

• Patient or legally authorized representative (LAR) provides authorization and/or consent per

institution and geographical requirements

• Patient has, or is intended to receive or be treated with, an eligible Medtronic product (Section

4.3)

• Patient is consented within the enrollment window of the therapy received, as applicable

Additional criteria may be required, refer to Condition/Therapy Appendix for further guidance.

Exclusion Criteria

• Patient who is, or is expected to be, inaccessible for follow-up

• Patient is excluded by local law

• Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may

confound the PSR results (i.e. no required intervention that could affect interpretation of allaround

product safety and/or effectiveness)