The FDA said today that it plans to make public information on four patient deaths linked to Boston Scientific’s (NYSE:BSX) Watchman heart implant once it receives it from the company.
The agency said it has asked the sponsor of a Watchman postmarket study for details on the deaths so it can include that information in its MAUDE adverse-events database. A report Wednesday in the Minneapolis StarTribune said the FDA is apparently allowing medtech companies to submit incomplete reports of device-related deaths.
