CONTINUED SAFETY MONITORING AND ADVERSE EVENT REPORTING

KEY POINTS

• Our focus on patient safety does not stop once a product comes to market.  We continuously monitor the safety and performance of all of our products through our postmarket surveillance process.
• Medtronic takes adverse events very seriously and investigates them thoroughly.  We report events to FDA as Medical Device Reports (MDRs), including instances where the device is not confirmed to have caused the event.
• Adverse event reports submitted to FDA as MDRs, have significant limitations.  These reports do not necessarily make determination or conclusion about whether the medical device caused the injury.  Due to their limitations, analyses of adverse event reports in FDA’s MAUDE database should be approached with caution, and any conclusions about device safety drawn from adverse events alone should be viewed with skepticism.

Overview

1. Continued Commitment to Safety After Product Approval or Clearance
   
   

   Our focus on patient safety does not stop once a product comes to market. We continuously monitor the safety and performance of our products through our postmarket surveillance process, which includes the receipt, analysis, investigation, and regulatory reporting of adverse events. Medtronic regularly performs trending analysis of events globally, in order to identify signals in the data that warrant further investigation and analysis, and voluntarily issue comprehensive, semiannual performance reports on certain products. In addition, we regularly collect data from postmarket clinical studies, review studies conducted by independent researchers, analyze scientific literature involving the use 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 safety and performance of our devices.

   In evaluating and monitoring our products, Medtronic carefully considers the totality of available field performance data and scientific evidence, including data from controlled postmarket clinical trials and studies conducted under real world-conditions, when available. Such studies provide additional and evidence regarding the safety, effectiveness and performance of our medical devices and therapies, and can allow for direct comparison to other products and therapies.

2. Analysis and Reporting of Adverse Event
   
   

   Medtronic takes safety signals very seriously and investigates them thoroughly. Of particular focus, adverse events involving death are closely reviewed and evaluated, often with direct involvement of internal medical professionals and at times in consultation with independent physician panels. Medtronic’s policy is to report these events, and also reports of serious injury, to FDA and other regulators even if a causal relationship to the device cannot be clearly established.

3. Limitations of Adverse Event Reports in MAUDE
   
   

   Adverse event reports for medical devices are publicly available on the FDA’s MAUDE database. It is critical to understand that adverse event reports submitted to MAUDE have significant and well-recognized limitations. An event may be deemed reportable even if the barest of information is available. Further, the reports do not necessarily make a determination or conclusion about whether the medical device had a relationship to, let alone caused, the injury.

   Other limitations of adverse event reports include the fact that such reports may be voluntarily filed by individuals with no medical training (e.g., patients, family members, or lawyers) and may contain limited or incomplete information. The reports can be duplicative and occasionally affected by external factors such as media reports or litigation. The MAUDE database does not provide total number of devices in use, so rates of adverse events cannot be calculated. Indeed, FDA has recognized that adverse events reports “cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices” and that “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.”¹ For these reasons, analyses of adverse event data should be approached with caution, and any conclusions about device safety drawn from adverse event reports alone should be viewed with skepticism.

See also:

• Safe and Responsible Product Development
• Responsible Promotion and Compliance
• Medical Device Labeling
• Medical Device Regulations