FAQs REGARDING RECENT MEDIA COVERAGE

Q&A RESPONSE TO QUESTIONS RAISED IN OCTOBER 12 and 26, 2018 ICIJ LETTERS

Q: It has been alleged that Medtronic’s business model is to develop a product and get it to market as quickly as possible. Do you dispute this characterization?

A: That is not accurate. At Medtronic, safety is our first and foremost priority and we reject any suggestion that Medtronic puts “innovation and profits” over safety. While we want to bring new, potentially life-saving therapies to patients as soon as possible, Medtronic will not offer a device or therapy to patients unless and until we have confirmed that the safety and efficacy profile is favorable in the context of the medical condition at issue and that we meet all of the appropriate regulatory requirements applicable in that market.

The process of medical device development, testing, and evaluation for safety and effectiveness is a highly developed scientific field. As a leading company developing new technology that extends patients’ lives, improves their health, and alleviates their pain, Medtronic has deep expertise in the testing and evaluation of new technology.

Our work in this area is overseen by leading regulators such as the U.S. Food and Drug Administration (FDA) and its counterparts in other countries around the world. These agencies also employ thousands of leading scientists, and they draw upon the expertise of independent scientific and medical experts. These officials review our risk analyses, our test plans and study designs, and they evaluate the results of our analyses. They oversee our work to monitor products that have been approved and are in the market, and they audit our facilities and management processes.

Each new technology, or each update or improvement to an existing technology, requires an evaluation plan based on that specific product, and what is new or changed and what risks may be incurred in its use. Regulatory agencies oversee, guide, and audit our decisions in all of these areas. Getting these processes right and ensuring the safety and effectiveness of our products is the core of our business. For this reason, Medtronic employs 86,000 employees, including scientists, clinical research personnel, and regulatory and quality experts, and, during the past ten years, Medtronic has spent more than $10 billion on research and development.

Q: What does Medtronic do to ensure that its products are safe and effective before bringing them to market?

A: Medtronic has a large team of dedicated professionals – including physicians, scientists and engineers – whose first and foremost priority is to ensure that all our medical devices and therapies meet the highest safety, efficacy, and performance standards. During development, our products are rigorously tested to ensure that they are safe. Because our devices and therapies are complex and innovative, before coming to market, we often seek advice from outside experts and regulators, including the FDA.

Our products are also subject to extensive testing, evaluation, and clearance or approval by FDA and other regulatory agencies. As of the end of July 2018, we have 317 active Medtronic-sponsored clinical studies. These include concept, feasibility, verification, and biocompatibility studies, as well as clinical trials. Medical experts at the FDA and other regulators examine the results of these studies, as well as other data, before clearing or approving our products for use by doctors and patients. Last year alone, Medtronic invested $2.25 billion developing and testing new devices and therapies, and that number is expected to grow in 2018. In addition to pre-market clinical testing, Medtronic is an industry leader in post-market study and surveillance, during which we monitor, track, report on, and communicate with our regulators regarding safety and efficacy signals that emerge from “real world” experience with many of our products after they have been cleared and are being used by physicians and patients around the globe.

Q: It has been alleged that Medtronic does not adequately monitor product safety after its products come to market. How do you respond?

A: At Medtronic, the safety of patients is our first and foremost priority, and our commitment to patient safety continues after our products are approved or cleared for patient use. In fact, Medtronic has been a market leader in driving post-market surveillance in the form of registries, data analytics, and real-world studies. For example, Medtronic has partnered with the Medical Device Innovation Consortium (MDIC) and the FDA, along with other industry participants, to help develop a first-of-its-kind electronic health record-based network to support collection and analysis of safety and efficacy data for medical devices across their full life cycle.

Medtronic also constantly monitors product safety. Medtronic’s post-market surveillance team – made up of highly-trained personnel including many medical professionals and engineers – continuously monitors the safety, efficacy, and performance of our medical devices and therapies in the U.S. and globally through our postmarket surveillance process. They regularly analyze adverse event data, collect and analyze data from postmarket clinical studies, review studies conducted by independent researchers, analyze scientific literature involving the performance of our products, and proactively seek out information and feedback from the numerous physicians and patients who use our products, all for the purpose of continuing to monitor and improve the performance and efficacy of our devices. We stand behind our surveillance systems, and we are confident that they represent best-in-class practices for our industry.

Q: Would you agree that adverse event reports are a valuable source of safety information about your products?

A: Adverse event data can help identify signals for potential safety issues that otherwise may not have been detected in clinical studies or other testing. However, adverse event data has significant and well-recognized limitations, and thus cannot be used to draw conclusions about causality. Thus, while adverse event data can raise questions, controlled studies are needed to get answers. As the FDA has stated, “the number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.”² That is why, in evaluating and monitoring the safety of our products, Medtronic carefully considers all of the available post-market data, including data collected from controlled clinical trials and real-world observational studies, when available.

Q: What information is needed for an injury to be considered an adverse event?

A: To be considered an “adverse event,” only the barest information is required. For medical devices, all that is needed is an allegation of an injury involving a device and a patient. These reports do not typically make any determination or conclusion about whether the medical device had any relationship to, let alone caused, the injury.

Q: What are some the strengths and limitations of adverse event data?

A: Adverse event data can help identify signals for potential safety issues that otherwise may not have been detected in clinical studies or other testing. However, adverse event data has significant and well-recognized limitations, and thus cannot be used to draw conclusions about causality. Limitations of adverse event reports include the fact that such reports may be voluntarily filed by individuals who do not have medical training (e.g., patients, family members, or lawyers), often contain limited or incomplete information, can be duplicative, and occasionally can be affected by external factors such as media reports or litigation.

Q: How does Medtronic evaluate potential safety issues with its medical devices and other therapies?

A: In evaluating potential safety issue for patients, we carefully consider the totality of available scientific evidence, frequently in cooperation with independent experts and consultants. In so doing, we put particular emphasis on data from controlled clinical trials and studies conducted under real-world conditions. Such studies provide the most reliable evidence regarding the safety and efficacy of our medical devices and therapies and allow direct comparisons to other products and therapies.

Q: How does Medtronic respond when it determines that a product must be recalled?

A: If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria. In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.

Q: Aren’t recalls of Medtronic products indicative of product safety and quality control concerns?

A: The word “recall” is a generic term that refers to various types of corrective actions, many of which do not involve product retrieval or market withdrawal. Some communications to customers about new risk information or labeling updates may be classified as a “recall.” For example, in May 2017, Medtronic notified customers using a specific insulin pump of a potential hardware issue that can result from rapid changes in atmospheric pressure, such as in flight during take-off or landing , and provided instructions to address this rare issue if it occurred. The product remained in the customers’ hands, but the communication enabled correction of any potential situation. So a “recall” does not necessarily indicate that a device is defective or dangerous.

Q: What steps does Medtronic take when it determines that a “recall” is necessary?

A: When Medtronic determines that a recall is necessary, we communicate with healthcare providers and/or patients, and provide recommendations to address the issues. Such communications can include letters, emails, calls, press releases, physician notifications, and social medial postings. Medtronic also informs FDA and other regulators of the action in accordance with applicable regulatory requirements. We strive to minimize the number of recalls related to our products, and we are proud of our safety record and the systems we have in place to detect, address, correct and communicate these issues when they do arise.

Q: Does Medtronic encourage sales representatives or Medtronic-sponsored doctors to promote unauthorized use of devices?

A: While physicians are free to use medical devices as they see fit based on their medical judgment (including “off-label” use), our sales and marketing representatives and consultants speaking on our behalf are not permitted to speak about or to encourage the use of any of our products in a manner that is at odds with the approved product labeling. Medtronic has an extensive policy regarding interactions with healthcare providers involving off-label uses of our products and conducts regular training of customer-facing employees in applicable countries. Medtronic’s Code of Conduct (“The Compass”) commits all our employees and those acting on our behalf to ethical behavior and requires employees to follow applicable laws and regulations, including those governing promotion of our products. Medtronic has made it a priority to educate its sales force and distributors on appropriate communication and to implement compliance programs that ensure any promotion or sale of its products is consistent with labeling.

Q: What steps has Medtronic taken to improve its compliance with regulations in the U.S. and worldwide?

A: Medtronic strongly believes in the integrity of its business practices and is proud of the compliance programs we have in place today. Medtronic requires its employees, and others acting on its behalf, to follow all applicable laws, regulations, company policies and industry standards whenever interacting with customers. Our Global Ethics & Compliance program was established by our Board of Directors, in conjunction with Medtronic senior management. The program includes: (1) written standards, including Medtronic’s Code of Conduct;¹ (2) leadership structure incorporating a Global Chief Ethics & Compliance Officer and Executive Compliance Committee; (3) education and training; (4) auditing and monitoring; (5) corrective action procedures; and (6) a compliance hotline, available around the globe in dozens of languages, which allows individuals to confidentially raise any compliance. Medtronic invests in robust programs for training our employees and agents globally on their responsibilities under these policies, and we take instances of non-compliance very seriously. Medtronic’s commitment to ethical and compliant conduct was recognized just last year when our Global Chief Ethics and Compliance Officer was honored with the prestigious PricewaterhouseCoopers (PwC) Award for Leadership in Advancement in the Medical Device Industry.