(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.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information was requested, and the following was obtained: on what date did the implant take place? n/a.What is the product code for this complaint? lxmc14.Lot #? n/a.Does the patient have any of the allergies to metals? no.Is the patient currently taking currently taking steroids / immunization drugs? n/a.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? unknown.Assuming yes.Was mesh used at time of implant? n/a.What was the reason for removal of the linx device? dr.Eggl said patient was unhappy and wanted linx removed.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.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.
|
(b)(4).Date sent: 07/29/2020.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.The unit was returned with bent links.Link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
|