MAUDE Adverse Event Report: TORAX MEDICAL, INC. LXC14; ANTI-REFLUX IMPLANT

Model Number LXC-[14]

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

Patient Problems Pyrosis/Heartburn (1883); Nausea (1970); Anxiety (2328); Depression (2361); Abdominal Distention (2601)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Event date: only event year known: 2022.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device batch number 4525, and no non-conformances were identified.Additional information was requested, and the following was obtained: do you have the linx product code? model # lxc14.Do you have the lot number and serial number (if applicable)? lot #4525, serial (b)(4).On what date was the device implanted? on (b)(6) 2013.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? no.Please specify the symptoms the patient was experiencing prior to implant (gerd reflux, dysphagia, pain during eating, etc., )? reflux, feelings of fullness, nausea, bloating.Esophageal pain at night.Had the patient had any diagnostic testing done to address the symptoms they experienced while the device was implanted? yes.If yes, what diagnostic testing was completed? bravo, barium study, egd and ph testing.Can you share the results of the diagnostic tests? yes, on request.Do they have an autoimmune disease? not current, previously diagnosed with graves disease.Is the omeprazole a prescribed medication or is over the counter medication? prescribed 40 mg.Are they 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 a 40 year old male with symptoms of gerd, ibs, anxiety, depression.The linx procedure implant was around 9 years ago.Recurrent symptoms of gerds.Patient reports he began feeling recurrent symptoms in summer 2021, described as a generalized abdominal fullness accompanied with mild nausea.He also experienced intermittent heartburn.He is presently taking omeprazole 40 mg once daily with mild relief.Bravo (b)(6) 2022 showed abnormal levels of acid reflux.The device is no longer providing him with relief of symptoms.

• Brand Name: LXC14
• 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: 15320230
• MDR Text Key: 305497038
• Report Number: 3008766073-2022-00171
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005158
• UDI-Public: 00855106005158
• 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: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2022

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: 03/19/2017
• Device Model Number: LXC-[14]
• Device Catalogue Number: LXC14
• Device Lot Number: 4525
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male