It was reported that a patient who had linx device placed 2 years ago with concomitant hiatal hernia repair via cruroplasty has had excellent response with only complaint being globus sensation.However, in the past several months experiencing reflux, nausea, postprandial pain.Upper gi series shows retention of contrast in esophagus secondary to significant narrowing at the linx device.Upper gi endoscopy was performed showing the narrowing and balloon dilatation was performed.The patient did not have any response to the dilatation and continues with the same symptoms without any improvement.No additional information was provided.
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(b)(4).Date sent: 6/22/2023.B3: unknown; captured as awareness date.D6a: exact implant date is unk.Implant year is 2021.Assumed first month of the year and first day of the month.No lot number was provided therefore a device history could not be done.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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