It was reported, "in (b)(6) 2013, my gi surgeon tested the symptoms for gerd and determined i was perfect candidate for the linx device.After wearing the device for six years now, recently i've developed pain, irritation, and breathing pressure at the device location on the esophagus.In recent months, my medical providers have performed a ct scan, colonoscopy, endoscopy, esophagram, and fluoroscopic evaluation of esophageal motility.All of these test results found no evidence of other medical issues.Therefore, i'm certain the linx is causing my extremely low quality of life.My gi surgeon is no longer at the hospital.Requesting how to get the linx device removed.
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(b)(4).Date sent: 04/08/2020.Device analysis: 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.The dhr for serial number (b)(6) from the lot number 4853 was reviewed.No ncs, defects, or reworks related to the product complaint were found.
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