This article has been updated with a response from Boston Scientific.
The FDA is apparently allowing medtech companies to submit incomplete reports of device-related deaths, according to a new report by the StarTribune of Minneapolis.
The news article says that the agency accepted one summary report covering four deaths related to Boston Scientific’s (NYSE:BSX) Watchman left atrial appendage closure device. The report contains no details about the events that led to the patients’ deaths nor about the postmarket surveillance study that revealed them. It refers only to a spreadsheet that the newspaper said the FDA declined to release.