(b)(4).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.Additional information was requested, and the following was received: device ¿ lxmc 13 was implanted on (b)(6) 2017.Lot# - 13122.Hospital ¿ (b)(6) hospital.Symptoms prior to linx implant in 2017 ¿ regurgitation, dysphasia, and heartburn.Dr (b)(6)¿s office ordered a follow-up upper gi study in (b)(6) 2018 which showed that the linx device looked to have some separation and could be on stomach more than esophagus ¿ according to dr (b)(6).This was a study they do as part of their research protocol.Patient was asymptomatic.On (b)(6) 2019 ¿ an abdominal x-ray was ordered by (b)(6) md (gi in (b)(6) ¿ (b)(6) general hospital) based on patient dealing with symptoms of chronic constipation.The x-ray image is the one originally sent to demonstrate a potential discontinuous linx device.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.Was it confirmed that the device did migrate onto the stomach? if yes, are there images available that show the migration? if yes, please send to (b)(4).Did the patient have a hiatal hernia at the time of removal?.
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