(b)(4).Date sent: 06/03/2020.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.Additional information was requested and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? assuming yes.Dr.(b)(6) has full diagnostic testing done prior to implantation.Results unknown.On what date did the implant take place? (b)(6) 2016.What is the lot number of the linx device? n/a ¿ dr.(b)(6) said he should have notated in patient records if necessary.When using the linx sizing device what technique was used to determine the size? linx sizing tool.Did the patient have an autoimmune disease? n/a.Is the patient currently taking steroids / immunization drugs? n/a.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? n/a.How severe was the dysphagia/odynophagia before intervention? n/a.Were there any intra-operative complications during implant? n/a.Was there any hiatal or crural repair done at the same time as the implant? n/a.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? not that were reported by dr.(b)(6).What was the reason for removal of the linx device? dysphagia.Was the device found in the correct position/geometry at the time of removal? n/a.Device is not returning-retained.
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