(b)(4).Event date: only event year known: 2020.Device remains implanted.No lot number was provided therefore a device history could not be done.Additional information received: the doctor has recommended a couple more attempts at dilation before considering any removal.Additional information was requested, and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? what is the lot number of the linx device? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? were there any intra-operative complications during implant? were there any other contributing factors that led to the er visit other than the reported dysphagia? if an x-ray was taken at the time of the er visit/hospitalization, or during the dilation, was the device found in the correct position/geometry? answers = there are no new additional details available at this time.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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