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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown.The lot was not provided; therefore, the manufacturing records could not be reviewed.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 surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure?.

Event Description

It was reported via journal article: title: long-term outcomes of patients receiving a magnetic sphincter augmentation device for gastroesophageal reflux.Authors: robert a.Ganz, steven a.Edmundowicz, paul a.Taiganides, john c.Lipham, c.Daniel smith, kenneth r.Devault, santiago horgan, garth jacobsen, james d.Luketich, christopher c.Smith, steven c.Schlack-haerer, shanu n.Kothari, christy m.Dunst, thomas j.Watson, jeffrey peters, brant k.Oelschlager, kyle a.Perry, scott melvin, willem a.Bemelman, andré j.P.M.Smout, dan dunn.Citation: clinical gastroenterology and hepatology.2016; 14: 671¿677.Doi: http://dx.Doi.Org/10.1016/j.Cgh.2015.05.028.Based on results from year 2 of a 5-year trial, in 2012 the us food and drug administration approved the use of a magnetic device to augment lower esophageal sphincter function in patients with gastroesophageal reflux disease (gerd).The authors reported the final results of 5 years of follow-up evaluation of patients who received this device.The authors performed a prospective study of the safety and efficacy of a magnetic device in 100 adults (52% male and 48% female patients; age range: 18 to 75 years old; bmi: 20 to 35) with gerd for 6 months or more, who were partially responsive to daily proton pump inhibitors (ppis) and had evidence of pathologic esophageal acid exposure, at 14 centers in the united states and the netherlands.The placement of a magnetic sphincter augmentation device (linx reflux management system; ethicon) is the only antireflux procedure that mechanically restores competency to the reflux barrier without using the gastric fundus.Reported complications included de novo esophagitis (n-5), persistent dysphagia (n-4) which required device removal with resolution after removal, persistent reflux symptoms (n-1) which required device removal , and persistent chest pain (n-1) which required device removal.In conclusion, this study showed that patients with chronic gerd and failed long-term ppi therapy benefited from surgical intervention with magnetic sphincter augmentation.Long-term safety and efficacy have been validated for this procedure.It should be considered a first-line therapy for patients and physicians seeking a fundic-sparing antireflux procedure.

• 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: milt garrett ; 4188 lexington avenue north; shoreview, MN
• MDR Report Key: 9081898
• MDR Text Key: 161096152
• Report Number: 3008766073-2019-00459
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2019

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: No Information
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/18/2019
• 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