Medtronic uses a prospective, long-term multi-center registry to monitor the performance of certain 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 2016 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.
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 Medtronic's 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.
Medtronic's 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, Medtronic’s 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, Medtronic’s sacral neuromodulation systems (neurostimulator, 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 60 centers that have contributed data for targeted drug delivery systems, 75 centers for spinal cord stimulation systems, 36 centers for deep brain stimulation, and 19 centers for sacral neuromodulation. There are 37, 41, 30, and 11 sites currently active for targeted drug delivery, spinal cord stimulation, deep brain stimulation, and sacral neuromodulation, respectively. 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.
Commitment to Quality
Medtronic's commitment to quality has long been stated in our mission, "To strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity, and service."
In line with this commitment we remain focused on sharing information and appropriate updates with customers on a regular basis. Thus, we are pleased to share the 9th Annual Medtronic Neurostimulation and Targeted Drug Delivery Systems Product Performance Report.
We are proud of our pioneering history at Medtronic and we realize the responsibility that comes with driving innovation in technology. As the first and only company to offer a full line of Spinal Cord Stimulation, Deep Brain Stimulation, Sacral Neuromodulation and Targeted Drug Delivery Systems therapies, we believe that performance reporting is even more important. We strive for better performance with every new product we develop. This report shows the evolution of product performance over time and also reveals advances in therapies that come with this experience and knowledge. Through this sharing of information we can enable physicians to best leverage state-of-the-art therapy delivery and also understand the performance of our devices to best manage patients.
We have tracked over 14,600 patients in our ongoing post-market registry. The registry has enrolled over 43,900 Neuromodulation system components. Components include pumps, catheters, neurostimulators, leads, and extensions. Data on other events not directly attributed to product performance are also included to provide additional information that may be important for patient management. Although gastric stimulation also involves neurostimulation, the performance of these systems is not included in the registry.
We welcome your suggestions on content, format, and any information you may have regarding the performance of Medtronic products. If you have questions or comments, please contact us through the information provided on the next page.
Thank you for your support.
Vice President, Clinical Research and Regulatory Affairs
We invite our customers to use this telephone number to call with suggestions, inquiries, or specific problems related to our products or the Product Performance Report.
PHONE: (800) 328-0810
Written requests or suggestions can be mailed to:
ATTN: Todd Weaver, PhD, MPH or Katherine Schiller, PhD
MAIL STOP: LS380
710 Medtronic Parkway NE, LS380
Minneapolis, MN 55432-5604
|Authors||Todd Weaver, PhD, MPH, Senior Clinical Research Manager |
Katherine Schiller, PhD, Senior Clinical Research Specialist
Brian Van Dorn, Senior Statistician
|External Medical Reviewers||Peter Konrad MD, PhD, Nashville, TN |
Karl Kreder, MD, Iowa City, IA
Robert Plunkett, MD, Buffalo, NY
John Sasaki, MD, Pomona, CA
Lisa Stearns, MD, Scottsdale, AZ
Michael Turner, MD, Indianapolis, IN
|Medtronic Review Board|| |
Christopher Irwin, Manager, Biostatistics
|Trademarks of Medtronic, Inc.|
|SynchroMed® implantable drug pump|
|Ascenda® intrathecal catheter||PrimeAdvanced® neurostimulator|
|Synergy® neurostimulator||Itrel®3 neurostimulator|
|Synergy Versitrel® neurostimulator||Pisces-Octad® lead|
|SynergyPlus+® neurostimulator||Pisces-Quad® lead|
|Restore® implantable neurostimulator||Resume® TL lead|
|RestoreAdvanced® neurostimulator||Specify™ lead|
|RestoreUltra® neurostimulator||Soletra® neurostimulator|
|RestoreSensor® neurostimulator||Kinetra® neurostimulator|
|InterStim® neurostimulator||Activa® neurostimulator|
|RestoreSensor® SureScan® MRI neurostimulator||RestoreUltra® SureScan® MRI neurostimulator|
|PrimeAdvanced® SureScan® MRI neurostimulator||SynergyCompact® neurostimulator|
|RestoreAdvanced® SureScan® MRI neurostimulator||Vectris® SureScan® leads|
2016 Medtronic Product Performance Report: Data through July 31, 2016.