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 Problems Dysphagia/ Odynophagia (1815); Nausea (1970); Pain (1994); Weight Changes (2607)

Event Date 08/07/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 8/22/2023.D6a: exact implant date is unknown.Assumed first day of the month and first month of the year.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 to ask the below questions? if yes, what is the surgeons name with contact information? when we reach out to the surgeon, they will ask for you date of birth, what is your date of birth? the below questions will be sent to your surgeon: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? on what date did the implant take place? will the device be explanted? if yes what is the explant date? what is the product code for the linx device that was removed? what is the lot number of the linx device? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? is the patient currently taking steroids / immunosuppressive drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? 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 states that he had a linx device placed five years ago and got relief.Patient reports that 4 weeks ago had abdominal pain and dysphagia.Patient then had esophageal dilation two weeks ago and since then cannot eat or drink.He reports increased abdominal pain, right in center of stomach.He has been in and out of the hospital and has lost 20 pounds.He reports that he feels like throwing up all the time.Surgeon suggested that patient see gi doc for egd.Gi doc wants to admit patient but doesn't have admitting privileges, so he is waiting for his linx surgeon to return his call but is considering going to the ed for his pain.

• 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: 17595604
• MDR Text Key: 321643144
• Report Number: 3008766073-2023-00173
• 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

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: 08/07/2023
• Initial Date FDA Received: 08/22/2023
• 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; Hospitalization