Catalog Number LXMC16 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Dysphagia/ Odynophagia (1815); No Code Available (3191)
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Event Date 11/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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(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.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.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? did the dysphagia improve after the device was implanted initially? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? what was the reason for removal of the linx device? was the device found in the correct position/geometry at the time of removal?.
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Event Description
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It was reported that there was a linx explant 43285, lxmc16/lot# 14416, on (b)(6) 2018.Patient complained of persistent dysphagia even after being dilated twice.There were no patient consequences.
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Manufacturer Narrative
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(b)(4).Date sent: 01/30/2019.The dhr of lot 14416 was reviewed.No ncs, reworks, or defects were found.As the device was not returned, an analysis investigation could not be performed.
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Search Alerts/Recalls
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