Implantable Systems Performance Registry (ISPR) Background

The Implantable Systems Performance Registry (ISPR) is a web-based registry that was voluntarily created by Medtronic to monitor the performance of infusion and spinal cord stimulation systems commercially available in the United States. The date of initiation into the ISPR for these systems was August 2003 and June 2004, respectively. Prior to the development of this registry, patient and product outcomes were typically measured by retrospectively analyzing data obtained from other data systems, including Returned Product Analysis (RPA), Enterprise Product Comment Reporting (EPCR), and the associated Medical Device Reporting (MDR) or MedWatch system. The ISPR allows for active surveillance of products through data collection. This information is used to guide future product development efforts aimed at improving product reliability and quality. The data is also used to measure progress toward improving product performance to fulfill regulatory requirements. In addition, data from the ISPR provide information about the treatment practices of physicians using these therapies.

This registry was initially designed to track performance of Medtronic’s implantable intrathecal drug delivery systems (infusion pumps and catheters). These infusion pumps deliver medications directly to the intrathecal space surrounding the spinal cord. This method of site-specific drug delivery decreases the dose requirements and side effects that may occur with systemic administration of the same drugs.

Medtronic spinal cord stimulation systems (spinal cord stimulators, leads, and extensions) for pain indications were later added to the registry. Spinal cord stimulation is the stimulation of the spinal cord or peripheral nerves by tiny electrical impulses. An implanted spinal cord stimulator sends electrical impulses through an implanted lead(s) to the nerves and these impulses block the pain messages to the brain for individuals with chronic pain.

Although some of our other therapies such as deep brain stimulation, gastric stimulation, and sacral nerve stimulation, involve neurostimulation, the performance of these products is not represented in our report at this time. We are committed to future updates and improvements in our reporting system.

The ISPR has collected data from 50 centers for intrathecal drug delivery systems and 42 centers for spinal cord stimulation systems across the United States. The ISPR centers that satisfied selection criteria and were activated for the registry participated in data collection for intrathecal drug delivery systems and/or spinal cord stimulation systems. Each ISPR center received Institutional Review Board (IRB) approval of the registry protocol and associated Informed Consent Forms (ICF). Registry patients agreed to sign an ICF prior to enrollment. Each ISPR center followed its standard clinical practice for implanting infusion and spinal cord stimulation systems including patient selection, implant methods, and post-implant therapy management. Centers were considered activated after receipt of the necessary documentation, completion of training and approval to access the web-based registry system.

Patient and device information was collected for patients who were implanted prior to enrollment into the ISPR (existing patients) and prospectively for patients who were enrolled and followed since implant (new patients). After enrollment and initial data collection, all patients were followed prospectively for adverse events requiring surgical intervention or until the abandonment of therapy. Patient status updates were obtained every 6 months. Participating investigators reported one primary event reason for each ISPR event along with patient symptoms and patient outcomes. Any detection methods used to determine patient or device outcomes were also obtained. Adverse events that did not require a surgical intervention or did not result in therapy abandonment are not represented in the device survival analyses that are presented in this report.

Medtronic 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 2nd Annual Medtronic Spinal Cord Stimulation and Intrathecal 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 and Intrathecal 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 ensure that physicians are able to best leverage state of the art therapy delivery and also understand the performance of our devices to best manage patients.  We also invite feedback to help drive continuous improvement.

Included in this report are product survival estimates for our commercially available implantable products used in the management of intractable non-malignant pain, malignant pain and spasticity.  These data are based on the tracking of over 5,100 patients in an ongoing surveillance study conducted in the United States called the Implantable Systems Performance Registry (ISPR). The Registry now includes nearly 13,000 pumps, catheters, spinal cord stimulators, leads, and extensions. Data on other events not directly attributed to product performance are also included in an effort to provide additional information that may impact patient care management.  The 2009 Product Performance Report includes the addition of product data for the 8709SC and 8731SC catheter models, RestoreUltra neurostimulator, and the 39565 lead model.

Although some of our other therapies such as deep brain stimulation, gastric stimulation, and sacral nerve stimulation, involve neurostimulation, the performance of these products is not represented in our report at this time because these products were not included in the ISPR during this time period.  We are committed to future updates and improvements in our reporting system.

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.

Andrina Hougham
Vice President, Emerging Therapies, Clinical Research, and Reimbursement
Medtronic, Inc.

Contact Information

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.

MEDTRONIC
PHONE: (800) 328-0810

E-MAIL

Written requests or suggestions can be mailed to:

MEDTRONIC
ATTN: Todd Weaver, PhD, MPH or Christine Boes, BS
MAIL STOP: RCE 375
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432

Editorial Staff

Editor	Andrina Hougham, Vice President, Emerging Therapies, Clinical Research, and Reimbursement
Authors	Todd Weaver, PhD, MPH, Principal Clinical Research Specialist Michelle Wells, MS, Clinical Research Specialist Katherine Stromberg, MS, Statistician
External Medical Reviewers	Peter Konrad MD, PhD, Nashville, TN Robert Plunkett, MD, Buffalo, NY John Sasaki, MD, Pomona, CA Lisa Stearns, MD, Scottsdale, AZ Michael Turner, MD, Indianapolis, IN
Medtronic Review Board	George Aram, Vice President, Quality and Compliance, Medtronic Susan Alpert, PhD, MD, Senior Vice President, Chief Quality and Regulatory Officer Christine Boes, BS, Senior Manager, Clinical Research and Quality Steven Broste, MS, Director, Biostatistics and Data Management Robert Coffey, MD, Medical Advisor Jonathan Eisenberg, JD, Vice President and Senior Legal Counsel Gary Lubben, Vice President, Marketing and Education Mary Owens, MD, Medical Safety Advisor Winifred Wu, Vice President, Regulatory Affairs

Trademarks of Medtronic, Inc.

SynchroMed® implantable drug pump	PrimeAdvanced® neurostimulator
Synergy® implantable neurostimulator	Itrel®3 stimulator
Synergy Versitrel® pulse generator	OctadTM lead
SynergyPlus+® neurostimulator	Pisces-Quad® lead
Restore® implantable neurostimulator	Resume® TL lead
RestoreAdvanced® neurostimulator	SpecifyTM lead
RestoreUltra® neurostimulator