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

Catalog Number LXMC14

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

Patient Problems Pyrosis/Heartburn (1883); Hernia (2240)

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 8/16/2023.B3: only event year known: 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 22442, and no related nonconformances were identified.Additional information was requested, and the following was obtained: do you have the linx product code? model lxmc14.Do you have the lot number and serial number? lot 22442.On what date was the device implanted? (b)(6) 2022.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? upper gi with ltd esph can you share the results of the diagnostic tests? there is a moderate amount of esophageal dysmotility with discoordinated primary contractions, tertiary contractions, and retention of a residual bolus of contrast within the esophagus.This bolus did clear with cued dry swallows.Lynx device in the distal esophagus at the gastroesophageal junction.Moderate-sized hiatal hernia inferior to the links device.Normal esophageal mucosa.Normal stomach and duodenal mucosa.Gastroesophageal reflux was observed during the exam, though is minimal.Do you have an autoimmune disease? no.Have you been prescribed medication by a doctor (not over the counter medication)? baclofen, hyoscyamine.If yes, what is the doctor prescribed medication? dr.Gould are you currently taking steroids / immunization drugs? no what are the next steps when it comes to the patients care? the surgical options would include a laparoscopic surgery to repair this hiatal hernia, possibly with mesh, and repositioning of the magnetic, sphincter, augmentation device, likely with a new implant.An alternative would be to laparoscopically repair this hiatal hernia, remove the device, and perform a gastric bypass if she continues to meet bmi criteria for bariatric surgery.We discuss the pros and cons of all these approaches.Her plan is to work on medical weight loss and reassess her symptom control.Should her symptoms persist or worsen despite the above, she is interested in surgery to repair the hiatal hernia and reposition/replace the device.I believe this is a reasonable approach.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 patient was experiencing sharp pains after having linx implanted some time ago.She has an appointment scheduled in the future with her doctor.

• 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 ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17558337
• MDR Text Key: 321381461
• Report Number: 3008766073-2023-00170
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2023

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: 08/06/2022
• Device Catalogue Number: LXMC14
• Device Lot Number: 22442
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2018
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female