MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Model Number LXMC15

Device Problems Device Appears to Trigger Rejection (1524); Appropriate Term/Code Not Available (3191)

Patient Problems Dysphagia/ Odynophagia (1815); Inflammation (1932)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information was requested, and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done? yes if yes, could you please share the results? see attached.What is meant by ¿the device was not functioning¿? not much motion with respect to the beads based on modified upper gi so they maybe densely encased in scar tissue.What is the product code for the linx device that was removed? nothing removed yet! what is the lot number of the linx device? 28562 size 15.When using the linx sizing device what technique was used to determine the size? measured 3 times and device popped open at size 12 so a size 15 was chosen.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunosuppressive drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no.How severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? yes.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that post- op to the linx procedure, the patient was stating he is having issues swallowing, so the doctor sent him to the gastroenterologist to have a balloon dilation procedure that was done on last (b)(6) 2021.They enlarged it two centimeters, and was told that was the max it could go to enlarge.After the procedure, the patient stated he was still experiencing dysphagia.The patient called the surgeon one month ago and the surgeon sent him to get an upper gi.That procedure showed the device was not functioning.The device is still implanted.The patient is in contact with the surgeon and is thinking about his possibilities before making any decisions.

Manufacturer Narrative

(b)(4); date sent: 11/3/2022.Photo analysis: the op.Notes were reviewed by a medical safety officer.As per medical safety officer: "nothing to add.Dysphagia requiring dilation.Gastritis.Intact device".A hands-on analysis is necessary to determine the cause of failure.A manufacturing record evaluation was performed for the finished device batch number 28562 , and no non-conformances were identified.

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview, MN ; 3035526892
• MDR Report Key: 15640786
• MDR Text Key: 302113443
• Report Number: 3008766073-2022-00207
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

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: LXMC15
• Device Catalogue Number: LXMC15
• Device Lot Number: 28562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 11/02/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male