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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pyrosis/Heartburn (1883)

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 3/16/2023.Investigation summary: this report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.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: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.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

Title: the effectiveness of the magnetic ring (linx) device in managing reflux after sleeve gastrectomy; long term results: a seven-years¿ experience.Authors: abdelkader hawasli , shoshana hallowell.Citation cite: hawasli et al.Mini-invasive surg 2023;7:4.Doi: 10.20517/2574-1225.2022.64.First patient to have the mr device linx (ethicon j&j cincinnati, oh) placement to manage her reflux after sg was done in january 2015.Since then and until december 2021, surgeon implanted the mr device in seventeen patients to manage their reflux after sg, including fourteen females and three males, with a mean age of 54 ± 12 years.Their initial mean weight at the time of placement of the mr device was 180 ± 45 lbs.With a mean bmi of 31 ± 6 kg/m2.The mean time between their sg and the placement of the mr device was 41 ± 19 months.Our endpoint was complete resolution of reflux after > 3 years of implantation.All patients had pre-operative barium swallow, high-resolution esophageal motility and upper endoscopy with 48-hour ph monitoring using the bravo capsule.Reported complications included severe post-operative dysphagia (n=2) , patients developed a recurrent reflux (n=11), recurrent reflux due to a broken connection between the beads leading to an open mr device (n=3), in conclusion the mr device is a valuable tool in treating reflux after sg in spite of its potential risk of recurrence.Results can be interpreted as being dissatisfying if complete resolution is the goal.Larger studies, with more than 3 year follow up, are needed before a final decision is made on its value in the bariatric population.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 16552615
• MDR Text Key: 311395524
• Report Number: 3008766073-2023-00042
• 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: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2023

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
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/16/2023
• 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