Neuromodulation Product Performance SUMMARY OF DATA FROM THE MEDTRONIC POST-MARKET REGISTRY

Introduction

Medtronic uses a prospective, long-term multi-center registry to monitor the performance of certain neuromodulation products at selected centers. The registry is currently conducted utilizing two protocols titled the Implantable Systems Performance Registry (ISPR) and the Product Surveillance Registry (PSR). Both protocols collect data on the performance of Medtronic products; however, PSR captures further information on select patient reported outcomes. Active patients enrolled under the ISPR protocol are in the process of transitioning to the PSR protocol. This 2017 Product Performance Report provides data on the devices followed in the registry. Medtronic also incorporates the findings of Returned Product Analysis (RPA) for devices followed in the registry that are returned to Medtronic.

Depending upon geography, this report may contain information outside approved labeling for Medtronic's commercially available devices. It is recognized that healthcare providers prescribe approved therapies to meet specific patient needs; however, Medtronic only directs the use of its products according to geography-specific, approved labeling.


PRODUCT PERFORMANCE REPORTS BY SYSTEM

Deep Brain Stimulation Systems

Spinal cord stimulation tables and graphs in this report generated based on data collected between July 2009 and the report cut-off date of October 31, 2017. Thirty-eight centers, including sites in North America, Europe and South America, have enrolled and contributed patient data to the deep brain stimulation section of the report.

Sacral Neuromodulation Systems

Spinal cord stimulation tables and graphs in this report generated based on data collected between April 2010 and the report cut-off date of October 31, 2017. Twenty centers in North and South America enrolled and contributed patients to the sacral neuromodulation section of the report.

Spinal Cord Stimulation Systems

Spinal cord stimulation tables and graphs in this report were generated based on data collected between June 2004 and the report cut-off date of October 31, 2017. Seventy-nine centers in North America, Europe and South America, have enrolled and contributed patient data to the spinal cord stimulation section of the report.

TARGETED DRUG DELIVERY SYSTEMS

Targeted drug delivery tables and graphs were generated based on data collected between August 7, 2003 and the report cut-off date of October 31, 2017. Sixty-four centers in America, Europe and South America enrolled and contributed patient data to the targeted drug delivery systems section of the report.