MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK LINX MAGNETIC IMPLANT; ANTI-REFLUX IMPLANT

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Arthritis (1723); Autoimmune Disorder (1732); Pyrosis/Heartburn (1883); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/15/2022

Event Type  malfunction  

Event Description

It was reported that the patients doctor wants to restart her on ppi¿s was on omeprazole for 8+ years prior to linx, which did not cure the reflux and ultimately caused osteoporosis.The reflux has persisted.

Manufacturer Narrative

(b)(4).Event date: unknown; captured as awareness date.Exact implant date unknown.Assume the first day of the month the device was implanted.No lot number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: please confirm the country, where are you located it? do you have the linx product code? do you have the lot number and serial number (if applicable)? have you had any diagnostic testing done to address the symptoms you experienced while the device was implanted? if yes, what diagnostic testing were completed? can you share the results of the diagnostic tests? do you have an autoimmune disease? have you been prescribed medication by a doctor (not over the counter medication)? if yes, what is the doctor prescribed medication? are you currently taking steroids / immunization drugs? if the device is ever removed at a future date, please contact productcomplaint1@its.Jnj.Com and reference (b)(4).Answer - the diagnosis from the surgeon who initially placed the linx (have an appointment with him on (b)(6) 2022) or the diagnosis from my current gi at (b)(6) clinic, who wants me to restart on omeprazole because i may end up with esophageal cancer? not sure what the purpose of linx would be if i start on ppi's again, that's why i'll be traveling to (b)(6) to meet with the dr.(b)(6) as autoimmune diseases, i was diagnosed with hashimoto's, arthritis and possibly fibromyalgia.I was provided with pre-surgery cd's, and after procedure i was only given a card for mri precautions, however, there is no product or serial numbers thereon.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.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: orla o'mahony ; 4188 lexington avenue north; shoreview 55126 ; 329348013
• MDR Report Key: 15504023
• MDR Text Key: 306319519
• Report Number: 3008766073-2022-00196
• Device Sequence Number: 1
• Product Code: LEI
• 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
• Report Date: 09/28/2022

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 Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1