Registry Background Neuromodulation Product Performance

Medtronic uses a prospective, long-term multi-center registry to monitor the performance of certain products at selected centers titled the Product Surveillance Registry (PSR). This registry was initially created by Medtronic to monitor the performance of commercially available target drug delivery (TDD) and spinal cord stimulation (PSTM) systems. Later on deep brain stimulation (DBS) and sacral neuromodulation (SNM) were added to the registry. This 2019 Product Performance Report (PPR) 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 the Medtronic 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.

The registry has collected data from centers across North America, Europe, South America, and Asia. There have been 76 centers that have contributed data for TDD systems, 84 centers for PSTM systems, 43 centers for DBS systems, and 23 centers for SNM systems. Each registry center received Institutional Review Board or Medical Ethics Committee approval of the registry protocol and associated Informed Consent Forms (ICF). Registry patients signed an ICF prior to enrollment. Each registry center followed its standard clinical practice for device system implantation including patient selection, implant methods, and post-implant therapy management. Centers were activated after receipt of the necessary documentation, completion of training, and approval to access the web-based registry system.