MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Model Number LXMC14

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Inflammation (1932); Nausea (1970); Pain (1994); Vomiting (2144); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 01/04/2022

Event Type  malfunction  

Event Description

It was reported a linx device was implanted in 2017 or 2018 and they are experiencing return gerd, food getting stuck or coming back up, esophageal spasms, pressure/pain and chest pressure.

Manufacturer Narrative

(b)(4).Captured as awareness date.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.Additional information was requested, and the following was obtained: is there any plans for explant? if yes could you please share information.Were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? please specify the symptoms the patient was experiencing prior to implant (gerd reflux, dysphagia, pain during eating, etc., )? had the patient had any diagnostic testing done to address the symptoms they experienced while the device was implanted? if yes, what diagnostic testing was completed? can you share the results of the diagnostic tests? do they have an autoimmune disease? has the patient been prescribed medication by a doctor (not over the counter medication)? if yes, what is the doctor prescribed medication? are they currently taking steroids / immunization drugs? answer = i have seen a surgeon and just completed an esophagram today and will be having an egd on (b)(6).With all the problems that i¿m having i am seriously considering explanting the linx.I¿ll be awaiting my test results to decide about explanation.I do not have a date set yet.There were not any intraoperative problems that i am aware of.I did have a hiatal hernia repair at the same time as the linx implantation.I had gerd that continued to get worse due to a non-functioning lower esophageal sphincter, chest pain, gastritis, nausea.I had multiple egd¿s, manometry, and ph testing prior to implantation.No autoimmune diseases.I currently take protonix 40mg, pepcid 20mg, bentyl 10mg, carafate 1g , and steroids off and on to treat pain/ pressure, inflammation and esophageal spasms since implantation.I will need to get my testing that i had done from my dr and have it all emailed to this address, if needed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 2/22/2022.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.If the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device batch number 17192, and no non-conformances were identified.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 13314706
• MDR Text Key: 284735776
• Report Number: 3008766073-2022-00022
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• Combination Product (y/n): N
• 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: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2021
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Device Lot Number: 17192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2022
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: 02/22/2022
• Supplement Dates FDA Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1