A1.-a6.No patient information was provided.D4.No serial number has been provided, so udi and expiration date could not be determined.H4.As a serial number has not been provided, manufacture date is unknown.H10.Livanova manufactures the protekduo.The event occurred in oklahoma city, oklahoma.Livanova has attempted to gather additional information about the event, including details of each event (e.G.Event date), the alleged relationship between the events and the livanova device, and other information about what has occurred.During a discussion with dr.Brewer, he indicated that specific details regarding this event (e.G.Event date, patient information, device information, etc.) were not recorded and could not be provided.During the follow-up communication, dr.Brewer indicated that severe tricuspid regurgitation was identified on a patient who suffered from rv disfunction prior to surgery, and the protekduo needed to be run at a higher rate in order to get septal balance.The customer did not know the valve condition prior to implantation and believes the device contributed to the regurgitation in some way.The patient was on support for 24-48 hours prior to the event and had the protekduo removed and a central rvad was put into place following the tricuspid regurgitation.At this time, there is no known malfunction of the protekduo that has been reported and it is unclear if any relationship exists between the reported adverse events and the livanova device.As device information was not provided, a review of the dhr could not be performed.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.H3 other text : device has not been made available.
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