Medtronic Product Surveillance Registry
- Study HIC#:1303011669REG
- Last Updated:06/02/2024
To provide continuing evaluation and periodic reporting of safety and effectiveness of market-released Medtronic products for their intended use.
(To collect information over time about how post-market Medtronic products are working and/or the outcome of the treatment.)
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Janet Guarino
- Phone Number: 1-203-747-7318
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
To provide continuing evaluation and periodic reporting of safety and effectiveness of market-released Medtronic products for their intended use.
(To collect information over time about how post-market Medtronic products are working and/or the outcome of the treatment.)
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
- 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 all around product safety and/or effectiveness)
Additional criteria may be required, refer to Condition/Therapy Appendix for further guidance.