(b)(4).Date sent: 3/24/2023.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.No lot number was provided therefore a device history could not be done.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: has the patient had any dilations, egd, or other procedure between the linx implant and discovery of the erosion? please describe and include the dates of the procedures.Are pictures or videos available? how many beads eroded? where were the eroded beads positioned? which best describes the device removal approach? endoscopically removed the eroded beads initially & laparoscopically removed the device at a later date.Endoscopically removed the eroded beads & laparoscopically removed the device the same day.Endoscopically removed the entire device.Laparoscopically removed the entire device.Was the patient stented? what is the current condition of the patient? prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? 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 / immunosuppressive 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? was ph testing performed prior to explant to confirm recurrent reflux? after implant, was the device initially effective in controlling reflux? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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(b)(4).Date sent: 5/9/2023.Investigation summary overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.
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