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); Muscle Spasm(s) (1966); Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 09/11/2019.Date of event: unknown.Resubmitting as the medwatch report was stuck in ack2.The original submission was made within the 30 day reporting time line.The lot was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported via journal article: title: the linx reflux management system: confirmed safety and efficacy now at 4 years.Author/s: john c.Lipham ¿ tom r.Demeester ¿ robert a.Ganz ¿ luigi bonavina ¿ greta saino ¿ daniel h.Dunn ¿ paul fockens ¿ willem bemelman.Citation: surg endosc.2012; 26: 2944¿2949.Doi: 10.1007/s00464-012-2289-1.Sphincter augmentation with the linx reflux management system (ethicon) is a surgical option for patients with chronic gastroesophageal disease (gerd) and an inadequate response to proton pump inhibitors (ppis).Clinical experience with sphincter augmentation is now available out to 4 years.In a multicenter, prospective, single-arm study, 44 patients (age range: 18 to 75 years old; 26 male and 18 female patients) underwent a laparoscopic surgical procedure for placement of the linx reflux management system (ethicon) around the gastroesophageal junction (gej).Sphincter augmentation improves the reflux barrier via the use of a flexible and expandable device that creates resistance to abnormal opening of the sphincter rather than adding bulk to the les or tightening the sphincter by plication or radiofrequency ablation.Reported complications included persistent dysphagia (n-1) that resolved following removal of the device 226 days after implant; this patient underwent a nissen fundoplication at a later date, chest pain with suspected esophageal spasm (n-1) in which the patient was hospitalized and given sublingual nitroglycerin.The patient was discharged after a short hospital stay and the pain resolved 2 months post implant, dysphagia (n-20) in which the dysphagia was generally mild and resolved by 3 months and one patient had the device removed, continued symptoms of gerd (n-1) and elected to have a nissen fundoplication 1,302 days post implant, and inability to belch/vomit (n-2).In conclusion, the authors found sphincter augmentation with the linx reflux management system (ethicon) to be a safe and effective treatment for patients with chronic gerd and incomplete symptom relief while taking ppis.Device erosion and migration have not been reported and clinical benefits have been maintained long term.Sphincter augmentation is an alternative surgical treatment option to improve the reflux barrier and has the potential to improve the lives of patients suffering from gerd without causing harm and significant side effects.

• 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: 9295546
• MDR Text Key: 165597150
• Report Number: 3008766073-2019-00432
• 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: Physician
• Type of Report: Initial
• Report Date: 08/14/2019

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: Health Professional
• Device Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 11/08/2019
• 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