(b)(4).Date sent: 06/12/2020.The dhr for lot 21918 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information was requested and received: on what date did the implant take place? (b)(6) 2018.Does the patient have any of the allergies to metals? no if so, what test have been done to test for metal allergies.Na.Is the patient currently taking currently taking steroids / immunization drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no.Was there any hiatal or crural repair done at the same time as the implant? yes.Was mesh used at time of implant? unknown.What was the reason for removal of the linx device? dysphagia.At the time of removal, was the device found in the correct position/geometry at the time of removal? yes.Have the symptoms resolved since the device was explanted? unknown.
|