On (b)(6) 2016 email from distributor notifying us of death by myocardial infarction two hours after ect treatment.On (b)(6) 2016 our quality manager responded with a series of questions about the event and the device used.Received no response.On (b)(6) 2016 our international manager requested the answers to the questions previously sent.On (b)(6) 2016 our distributor responded and said he had been on vacation, and he now needed to talk with others before he could answer the questions.On (b)(6) 2016 our international manager again requested response.On (b)(6) 2016 our international manager emailed the distributor again and sent a copy of the distributor agreement along with an adverse event form to be filled out an returned.We have received no further responses from our distributor.
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