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

Catalog Number UNK LINX MAGNETIC IMPLANT

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

Patient Problems Dysphagia/ Odynophagia (1815); Nausea (1970); Pain (1994)

Event Date 07/25/2023

Event Type  Injury  

Event Description

It was reported that a linx device was implanted and the patient has been having problems.There was a hiatal surgery at the same time.After two or three months, the patient had to go back to a gi specialist who called her surgeon for advice on what he should do.The gi stretched the device to open it up more so food could go down.That was done in march due to food getting stuck and would not go down.In june she had to have a barium swallow test.Went to ent to check soreness in throat.He prescribed a spasm medication.That did not work so she went to a swelling neurologist for three appointments.They did a test showing pills went down with no problems.They gave her three pages of exercise to do on her throat.After three weeks of exercise, the pain became worse.A bad throat pain that goes from the back of throat into the chest.Patient went back to surgeon, and he prescribed blood pressure medicine.Patient went back to regular doctor and stated she did not know what to do.She is unsure if it is dysphagia.She went to regular doctor, and he prescribed nitroglycerin and stated she could take up to three.Patient had an episode from not taking the nitroglycerin.She had another episode.Patient¿s throat is currently feeling raw and sore.She is also experiencing nausea every morning and bowel issues.

Manufacturer Narrative

(b)(4).Date sent: 8/9/2023.B3: unknown; captured as awareness date.No lot number was provided therefore a device history could not be done.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: do we have permission to reach out to your surgeon? if yes, please provide a name and the contact information.When we contact your surgeon, they will ask for your date of birth.What is your date of birth? the below questions will be sent to your surgeon.What is the linx product code? what is the linx lot number? prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? were there any intra-operative complications during implant? what is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? if the device is scheduled for removal, what is the operation date of the removal? when and if the linx device is removed, may we ask that the device be returned for analysis? 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.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 17491458
• MDR Text Key: 320709635
• Report Number: 3008766073-2023-00154
• 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: 08/09/2023

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 Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/09/2023
• 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
• Patient Outcome(s): Required Intervention