Medtronic Product Surveillance Registry
- Study HIC#:2000033773
- Last Updated:03/04/2024
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)
Contact Us
For more information about this study, including how to volunteer, contact:
Matthew Kluko
- Phone Number: 1-203-737-2543
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Trial Purpose and Description
Serve as an ongoing source of product performance, patient safety and clinical outcomes information associated with the use of market released products.
Eligibility Criteria
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)
