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 2018 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 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 was created by Medtronic to monitor the performance of commercially available infusion and spinal cord stimulation systems. These systems were initiated into the registry in August 2003 and June 2004, respectively. Prior to the development of the registry, Medtronic Neuromodulation typically evaluated patient and product outcomes by retrospectively analyzing data from Returned Product Analysis (RPA) and complaints data. The registry allows Medtronic to prospectively capture valuable real-world information that can be used in conjunction with these retrospective and passive data sources. This information is used to guide future product development efforts aimed at improving product reliability and quality. The data are also used to measure progress toward improving product performance to fulfill regulatory requirements. In addition, data from the registry provide information about the treatment practices of physicians using these therapies.

This registry was initially designed to track performance of the Medtronic implantable targeted drug delivery systems (infusion pumps and catheters). These surgically-placed devices deliver prescribed medication directly to the fluid around the spinal cord for the treatment of chronic pain or severe spasticity.

The Medtronic spinal cord stimulation systems (spinal cord neurostimulators, leads, and extensions) for pain indications were later added to the registry. Implanted spinal cord neurostimulators send electrical impulses to the spinal cord.

In July 2009, the Medtronic deep brain stimulation systems (deep brain neurostimulators, leads, and extensions) were included in the registry. Deep brain stimulation (DBS) uses a surgically implanted neurostimulator to deliver electrical stimulation to targeted areas in the brain.

In April 2010, the Medtronic sacral neuromodulation systems (neurostimulators, leads, and extensions) were added to the registry. This implantable system sends electrical pulses through a lead to the sacral nerves to modulate the neural activity that influences the behavior of the pelvic floor, lower urinary tract, urinary and anal sphincters, and colon.

The registry has collected data from centers across the United States, Europe, and South America. There have been 71 centers that have contributed data for targeted drug delivery systems, 82 centers for spinal cord stimulation systems, 38 centers for deep brain stimulation, and 20 centers for sacral neuromodulation. 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.