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

Catalog Number LXMC14

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

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 11/9/2023.B3: only event year known: 2023.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 received: patient mentioned that he goes through the metal detectors at veterans affairs quite often and is curious if this machine may have caused the defect in his linx and if the 2 dilations contributed to the defect in his device.Patient indicated that his symptoms are worse than before implant.Patient has a 15 bead linx lxmc15 s# or lot# 4328l implanted (b)(6) 2021 by dr.(b)(6).The procedure was done by robotic/laparoscopic.Patient is going to see is surgeon and will be discussing if the device needs to be removed.Patient will call back after his meeting with his surgeon to update his file.When/if the device is explanted please let us know at productcomplaint1@its.Jnj.Com and reference (b)(4).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 a linx was implanted in 2019 after a failed nissen that before the implant the patient was having severe reflux then no reflux.About the past year and the patient has been been having some reflux that has been controllable with tums.The gi doctor did a swallow study which found that some times food is getting stuck above the linx and leaking liquids.Barium swallow shows that liquids pass through immediately showing that the linx is leaking liquids.Implant surgeon offered to remove the device but the patient would rather keep it since it is a huge improvement over what he was experiencing before.

Manufacturer Narrative

(b)(4).Date sent: 11/20/2023.Additional information was requested, and the following was obtained: what is your date of birth? (b)(6) 1962.

Manufacturer Narrative

(b)(4).Date sent: 12/5/2023.Additional information was requested, and the following was obtained: do you have the linx product code? ring linx reflux sz 14-log1501803208.Do you have the lot number and serial number (if applicable)? lot no.19821.On what date was the device implanted? (b)(6) 2019.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? yes, i had a barium swallow study.Can you share the results of the diagnostic tests? solid foods (barium pill) get temporarily stuck above the linx.Liquids flow through immediately.Do you have an autoimmune disease? no.Have you been prescribed medication by a doctor (not over the counter medication)? i do not currently take any prescription medications for reflux.If yes, what is the doctor prescribed medication? n/a.Are you currently taking steroids / immunization drugs.? no.A manufacturing record evaluation was performed for the finished device 19821 number, and no non-conformances related to the malfunction were identified.Photo anlaysis: an x-ray image of the device in vivo was reviewed by a medical safety officer.As per medical safety officer: "the image demonstrates an intact linx device located below the diaphragm." the mechanism/cause of failure is unknown as a hands-on analysis of the device is necessary to determine the cause of failure.No further investigation can be completed at this point.

• Brand Name: 1.5T LINX, 14B
• 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: 18101706
• MDR Text Key: 327732616
• Report Number: 3008766073-2023-00215
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LXMC14
• Device Lot Number: 19821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR