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); No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Hemorrhage/Bleeding (1888)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Publication year of 2020.This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot 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.Kindly confirm if the presumed linx device (per note on the compliance with ethical standard) can be considered as an ethicon device for this article since no other device was mentioned?.

Event Description

It was reported via journal article: title: regression of barrett¿s esophagus after magnetic sphincter augmentation: intermediate-term results.Author: colin p.Dunn, justin c.Henning, jason a.Sterris, paul won, caitlin houghton, nikolai a.Bildzukewicz, john c.Lipham.Citation: doi: https://doi.Org/10.1007/s00464-020-08074-6.This is a retrospective review of 87 patients (male n=55, median bmi was 26.95) with biopsy-proven barrett¿s esophagus who underwent magnetic sphincter augmentation with linx device (ethicon) between april 2007 and september 2019.Perioperative complications of intra-operative bleeding (n=1) which required additional port placement for control (though no blood was transfused) was reported and a patient was readmitted for dysphagia (n=1) which was resolved with a course of steroids were reported.Postoperatively, patients had unchanged results of their latest biopsy (n=75%) and some patients showed who had originally short-length barret¿s had lengthening of their barrett¿s segment (n=5).Msa reduces esophageal acid exposure and can lead to reduction or resolution of barrett¿s esophagus.Msa is also effective at preventing progression of metaplasia to dysplasia or neoplasia.This effect remains consistent even after 2 years of follow-up.

• 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: kara ditty-bovard ; 4188 lexington avenue north; shoreview, MN 55126 ; 6107428552
• MDR Report Key: 11568714
• MDR Text Key: 259465434
• Report Number: 3008766073-2021-00050
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• 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
• Date Manufacturer Received: 03/08/2021
• 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