MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT

Model Number LXMC16

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 12/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 number was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: 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? is the patient currently taking steroids / immunization drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? were there any other contributing factors that led to the removal of the device other than the reported dysphagia? besides dysphagia, what was the reason for removal of the linx device? was the device found in the correct position/geometry at the time of removal?.

Event Description

It was reported that two weeks post-operative after a linx implant the patient had dysphagia and could not swallow.The patient was treated with steroids both in i.V.Form and oral.This did not resolve the systems and the device was explanted.

Manufacturer Narrative

(b)(4).Date sent: 1/12/2021.Additional information was requested, and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done? na if yes, could you please share the results? na.What is the lot number of the linx device? na.When using the linx sizing device what technique was used to determine the size? na.Did the patient have an autoimmune disease? na.Is the patient currently taking steroids / immunization drugs? na.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? na.How severe was the dysphagia/odynophagia before intervention? severe, patient could not swallow anything.Were there any intra-operative complications during implant? na.Was there any hiatal or crural repair done at the same time as the implant? na.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? na.Besides dysphagia, what was the reason for removal of the linx device? na.Was the device found in the correct position/geometry at the time of removal? na.

• Brand Name: LINX 1.5 16 BEAD US
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 11096752
• MDR Text Key: 225725683
• Report Number: 3008766073-2020-00207
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LXMC16
• Device Catalogue Number: LXMC16
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention