MDR submitted to the FDA are showing an increase in the number of patient strokes (Cerebrovascular Accidents/CVA). The increase is in both absolute and relative numbers. Specifically, over the past 10 years the number of strokes reported has increased an average of 17%. If you narrow the range to the past 3 years only, the rate of increase jumps to an average of 40%.

When manufacturers prepare Medical Device Report (MDR) submissions to the FDA, they collect data from health care providers. The information coming from health care providers sometimes mentions that patient had a stroke in the course of using the manufacturer’s medical device. The cause of the stroke might or might not have anything to do with the device, nevertheless the manufacturer is required to submit that information to the FDA.

The numbers reported to the FDA in the past 10 years have shown a consistent increase with the exception of the 2015/2016 calendar years.



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