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 Chest Pain (1776); Dysphagia/ Odynophagia (1815); Paresis (1998); Vomiting (2144); Choking (2464)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 8/14/2023.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 was requested, and the following was obtained: linx implanted (b)(6) 2019.At this time i also had repair of a hiatal hernia in the same surgery.Have you had any diagnostic testing done to address the symptoms you experienced while the device was implanted? after the linx was implanted (months) i experienced serious pain in my chest similar to the pain i had had prior to the surgery which the surgeon had said was from the hiatal hernia.Since the hernia had supposedly been repaired i reported it to the surgeon and he ended up doing another egd on me to see if everything looked okay.He said everything was great with his surgery and that the pain i had had was most likely from my gall bladder.He said gall bladder pain can mimic hernia or heart pain.I continued to have the pain on and off for a year or more but it never became severe so i did not seek other medical help.I still get the pain infrequently.Since the onset of the current situation in march (possible gastroparesis and sometimes difficulty/pain with swallowing), i immediately reported my serious condition to the surgeon's office where they said i was no longer a patient and offered no help until i tracked down my own records and had them sent.After a couple scary, painful months i finally got a barium swallow and egd done through the surgeon.The swallow test showed nothing remarkable - no strictures.The egd: the swallowing mechanism and esophageal motility are unremarkable.Linx device appears to be in satisfactory position.Mild diffuse dilation of the esophagus.Mildly delayed transit of contrast through the gastroesophageal junction at the level of the linx device.There are no signs of esophageal stricture, mass, or ulceration.No hiatal hernia present.Gastroesophageal reflux occurred during the examination.(from surgeon's notes.) do you have an autoimmune disease: no.Have you been prescribed medication by a doctor (not over the counter medication)? reglan was prescribed for gastroparesis.Are you currently taking steroids/immunization drugs? no.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 hiatal hernia repair procedure that she recovered fine from the implant.In march of this year, patient woke up with partially digestive food coming up out of mouth and was choking.The surgeon doctor did a scope and a swallow test and said that the device was fine and hernia surgery was fine and that the only thing he saw was partially digestive food sitting in stomach and stated that she probably has gastroparesis.He also stated that there was no stricture and the barium swallow report also read no stricture were seen and everything looked fine.Patient started having problems swallowing and food was not going down all the time.It would be depending on what she was eating and if she was taking pills.Patient states it is painful and has to take many drinks.Patient was advice by her pcp that in looking from results, the linx is not closing and opening properly.Patient is currently have discomfort and states eating does not feel normal.

Manufacturer Narrative

(b)(4).Date sent: 9/13/2023.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, 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 lot number 19588, and no related nonconformances were identified.

• 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: 17545179
• MDR Text Key: 321235937
• Report Number: 3008766073-2023-00167
• 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
• Report Date: 09/13/2023

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 Expiration Date: 03/17/2022
• Device Catalogue Number: LXMC14
• Device Lot Number: 19588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention