(b)(4).Unknown.As the device was not returned, an analysis investigation could not be performed. a conclusion could not be reached as to what may have caused or contributed to the event. the lot was not provided; therefore, the manufacturing records evaluation could not be performed.The following was requested but not available: what is the product code for this complaint? what is the lot number of the device? what was the date of implant? if the device has been removed, what was the date of explant? what were the first clinical symptoms that provided evidence of an erosion and when did they first occur? has the patient had any dilations, egd, or other procedure between the linx implant and discovery of the erosion? please describe and include the dates of the procedures.Are pictures or videos available? how many beads eroded? where were the eroded beads positioned? which best describes the device removal approach? endoscopically removed the eroded beads initially & laparoscopically removed the device at a later date endoscopically removed the eroded beads & laparoscopically removed the device the same day endoscopically removed the entire device laparoscopically removed the entire device was the patient stented? what is the current condition of the patient? if information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.
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