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); Pain (1994)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported that via journal article: title: results from a prospective, multicenter study of reflux management with the linx system for gastroesophageal reflux disease after laparoscopic sleeve gastrectomy.Author(s) : william petraiuolo blue ash oh1 , leena khaitan chardon oh2 , michael hill saranac lake ny3 , michael michel summerville sc4 , patrick m chiasson md tucson az5 , philip woodworth lone tree co6 , reginald bell englewood co7 , carlos anciano greenville nc8 , ragui sadek somerset nj9 , aaron hoffman 1.Citation: 2022 abstracts 38th annual meeting of the american society for metabolic and bariatric surgery / surgery for obesity and related diseases 18 (2022) s1¿s89.The aim of this study is to confirm safety and efficacy of linx after laparoscopic sleeve gastrectomy.Patients had linx implantation were followed 12-months post-implant are involved in this study.Reported complications: (n=15) device-related and/or procedure-related adverse events including (n=2) who had dysphagia and pain which resolved without sequelae, (n=2) underwent explant.Conclusion: linx safety was confirmed post-lsg with an overall improvement of gerd symptoms and reduction in ppi use with explants within anticipated range.

Manufacturer Narrative

(b)(4).Date sent: 8/9/2023.B3: only event year known: 2022.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.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.

• 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: 17492096
• MDR Text Key: 320716409
• Report Number: 3008766073-2023-00160
• 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: 08/09/2023

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: 07/26/2023
• Initial Date FDA Received: 08/09/2023
• 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