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); Dyspnea (1816); Inflammation (1932); Nausea (1970); Pain (1994); Vomiting (2144); Abdominal Distention (2601); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown.Flatulence.The lot was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported via journal article: title: esophageal sphincter device for gastroesophageal reflux disease.Author/s: robert a.Ganz, m.D., jeffrey h.Peters, m.D., santiago horgan, m.D., willem a.Bemelman, m.D., ph.D., christy m.Dunst, m.D., steven a.Edmundowicz, m.D., john c.Lipham, m.D., james d.Luketich, m.D., w.Scott melvin, m.D., brant k.Oelschlager, m.D., steven c.Schlack-haerer, m.D., c.Daniel smith, m.D., christopher c.Smith, m.D., dan dunn, m.D., and paul a.Taiganides, m.D.Citation: n engl j med 368;8; february 21, 2013; doi: 10.1056/nejmoa1205544.The objective of the prospective, multicenter, single-group study was to evaluate safety and effectiveness of a new magnetic device to augment the lower esophageal sphincter.The study was designed as a 5-year prospective, multicenter, single-group evaluation of magnetic sphincter device.Between january and september 2009, 100 patients were enrolled in the study (52% male; 48% female; age range 18-75 years; median bmi 28 range 20-35), had at least a 6-month history of gastroesophageal reflux disease (gerd) and had a partial response to daily proton-pump inhibitors, with increased exposure to esophageal acid as confirmed by ph monitoring.Reported complications included mild dysphagia (n=47), moderate dysphagia (n=16), severe dysphagia (n=5) in which 3 patients had required removal of the device at 21, 31, and 93 days after implantation and had the event resolved, further 19 patients underwent esophageal dilation with 16 reporting improvement after the procedure; nausea (n=1) and vomiting (n=1) which the patients required rehospitalization 2 days after surgery, their symptoms resolved with conservative therapy.The device was then removed as part of the disease management at 489 days and 1062 days respectively post implantation; mild bloating (n=12), moderate bloating (n=2); mild pain (n=7), moderate pain (n=13), severe pain (n=5), which required device removal in 1 patient; mild odynophagia (n=4), moderate odynophagia (n=3), severe odynophagia (n=1); mild hiccups (n=7), moderate hiccups (n=1); mild nausea (n=3), moderate nausea (n=2), severe nausea (n=2); mild inability to belch or vomit (n=5), moderate inability to belch or vomit (n=1); mild decreased appetite (n=4); mild flatulence (n=2); mild belching (n=2); mild weight loss (n=2); moderate food impaction (n=1); mild globus sensation (n=1); mild irritable bowel syndrome or dyspepsia (n=1); moderate regurgitation of sticky mucus (n=1); mild uncomfortable feeling in chest (n=1); moderate vomiting (n=1); moderate persistent gerd (n=1); grade a esophagitis (n=3) developed at 1 year, grade a esophagitis (n=4) developed at 2 years, grade d esophagitis (n=1) develop at 1 year but showed complete resolution of esophagitis at 2 years.It was reported in the article that the mild intensity was defined as an awareness of signs or symptoms that did not interfere with usual activities, moderate as discomfort intense enough to cause interference with usual activities, and severe as incapacitating discomfort, with inability to perform work or usual activities.In conclusion, the single-group evaluation of 100 patients before and after sphincter augmentation with a magnetic device, exposure to esophageal acid decreased, reflux symptoms improved, and use of proton-pump inhibitors decreased.Clinical data clearly showed that the patients had heartburn symptoms despite ppi therapy, which resolved after magnetic augmentation.Follow-up studies are needed to assess long-term safety.

• 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: 9156412
• MDR Text Key: 163132836
• Report Number: 3008766073-2019-00517
• 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: 09/20/2019

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: 09/20/2019
• Initial Date FDA Received: 10/04/2019
• 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