On 12 sep 2022 syncardia received the outcome form for (b)(6) patient (b)(6) which listed the cause of death on (b)(6) 2022 as other: disconnected freedom driver with causes or contributing factors to the death as "his wife found him with disconnected freedom driver" and that the device did not cause or contribute to the patient's death.The tah-t was not explanted and no autopsy was performed.Per distributor, the wife come home from work and found patient on the floor with the freedom driver pumping but no values were on the display.The wife called the hospital and emergency personnel arrived but were unable to revive the patient.The distributor stated via phone conversation with syncardia personnel that they are not alleging any device malfunctions with either the tah-t nor the freedom driver.No additional information has been provided at this time.On 15 sep 2022 additional information from distributor: according to information from the hospital the patient (b)(6) probably committed suicide.Everything seemed normal.Family is shocked.No note or any indication of suicide.I have no information about second driver, no one can confirm that he was trying to make an exchange.We can say for sure that syncardia was not cause of the death.
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