(b)(4).Date sent: 06/12/2020.The lot was not provided; therefore, the manufacturing records evaluation could not be performed.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? on what date did the implant take place? what is the product code for the linx device that was removed? what is the lot number of the linx device? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? is the patient currently taking steroids / immunization drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? were there any other contributing factors that led to the removal of the device other than the reported dysphagia? was the device found in the correct position/geometry at the time of removal?.
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