MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 13B; ANTI-REFLUX IMPLANT

Model Number LXMC13

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); No Code Available (3191)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that on (b)(6) 2020, the linx device was explanted due to dysphagia.The device was implanted on (b)(6) 2020, and after six months the device was removed.The patient went through two rounds of balloon dilation.No issues during the removal of the device.

Manufacturer Narrative

(b)(4).Date sent: 11/4/2020.Lot 22983 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information was requested, and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done? per the surgeon yes.At the time the surgeon did not have access to the data.When using the linx sizing device what technique was used to determine the size? the placement technique was standard protocol.The device was placed at a plus 2 of pop off.Did the patient have an autoimmune disease? unknown.Is the patient currently taking steroids/immunization drugs? unknown.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? unknown.How severe was the dysphagia/odynophagia before intervention? unknown were there any intra-operative complications during implant? unknown was there any hiatal or crural repair done at the same time as the implant? yes were there any other contributing factors that led to the removal of the device other than the reported dysphagia? unknown what was the reason for removal of the linx device? complaints of dysphagia was the device found in the correct position/geometry at the time of removal? yes.Additional information from surgeon: implant date was (b)(6) 2020.We saw patient initially (b)(6) 2016 and she had egd showing medium-sized hiatal hernia, 24-hour ph study was negative for reflux at that time.Manometry (b)(6) 2016 showed normal sphincter pressures with appropriate relaxation.Ten swallows were intact.There was 100% bolus clearance.She had normal motility.She had a repeat egd in (b)(6) 2018 and bravo first day was normal as she slept all day and did not eat.The second day was highly positive with total time of ph less than 4 of 12.4%, demeester score 40.9.We did repeat manometry.I think issue with her was likely size 13 device was too large at time of placement, with probable capsule around but not between magnets, preventing opening and causing dysphagia.

• Brand Name: 1.5T LINX, 13B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10662260
• MDR Text Key: 215265828
• Report Number: 3008766073-2020-00158
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• 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: 09/23/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2022
• Device Model Number: LXMC13
• Device Catalogue Number: LXMC13
• Device Lot Number: 22983
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 10/16/2020
• Supplement Dates FDA Received: 11/04/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention