(b)(4).Date sent: 08/27/2020.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot 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? on what date did the implant take place? 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? besides dsyphagia, what was the reason for removal of the linx device? was the device found in the correct position/geometry at the time of removal? is the device available to return for analysis? if yes, to whom should the shipper kit be sent to (please include full name and full address)? response: due to this surgeon not implanting answers are unknown.
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