MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK LINX MAGNETIC IMPLANT; ANTI-REFLUX IMPLANT

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Migration or Expulsion of Device (1395); Device Appears to Trigger Rejection (1524)

Patient Problems Dysphagia/ Odynophagia (1815); Pocket Erosion (2013)

Event Date 10/24/2023

Event Type  Injury  

Event Description

It was reported that a linx device was implanted in (b)(6) 2014.Exact day is unknown.The device does not allow solid food to pass.Patients doctor is suggesting it be stretched.Ct and barium swallow have been done.Had an endoscopy and the linx was eroded and needs to be removed.Waiting to schedule surgery.

Manufacturer Narrative

(b)(4).Date sent: 11/17/2023.D6a: exact implant date is unk.Assumed 1st day of the month.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: what is the product code? what is the lot number? what was the exact implant date? if and when the device is stretched or explanted please let us know at (b)(6) 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.

Manufacturer Narrative

(b)(4).Date sent: 12/29/2023.

Manufacturer Narrative

(b)(4).Date sent: 12/5/2023.Additional information was requested, and the following was obtained: dr that removed linx is (b)(6) at (b)(6) hospital.He only removed the linx, he did not implant it.Patient dob (b)(6) 1993.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: what was the exact date of implant? what is the product code? what is the lot number? if the device has been removed, what was the date of explant? what were the first clinical symptoms that provided evidence of an erosion and when did they first occur? has the patient had any dilations, egd, or other procedure between the linx implant and discovery of the erosion? please describe and include the dates of the procedures.Are pictures or videos available? how many beads eroded? where were the eroded beads positioned? which best describes the device removal approach? endoscopically removed the eroded beads initially and laparoscopically removed the device at a later date endoscopically removed the eroded beads & laparoscopically removed the device the same day endoscopically removed the entire device laparoscopically removed the entire device.Was the patient stented? what is the current condition of the patient?.

• 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: 18159099
• MDR Text Key: 328391652
• Report Number: 3008766073-2023-00228
• 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,Followup,Followup
• Report Date: 12/05/2023

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 Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 11/21/2023; 12/29/2023
• Supplement Dates FDA Received: 12/05/2023; 12/29/2023
• 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: 29 YR