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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Unexpected Therapeutic Results (1631)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 09/23/2019.Date of event: unknown.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/ antireflux surgery: who needs it? authors: ganz ra; peters j; horgan s; nuzhat a.Ahmad; joseph anderson; darren m.Brenner; andrew t.Chan; francis k.L.Chan; lin chang; tsutomu chiba; massimo colombo; b.Joseph elmunzer; alex ford; timothy b.Gardner; lauren b.Gerson; w.Ray kim; paul y.Kwo; josep m.Llovet; edward v.Loftus; julian panes; laurent peyrin- biroulet; joel h.Rubenstein; sameer saini; shiv k.Sarin; shamita b.Shah; pratima sharma; amit singal; jan tack; akbar waljee; kenneth k.Wang; alastair j.M.Watson.Citation: esophageal sphincter device for gastroesophageal reflux disease.N engl j med 2013; 368; 8:719¿727.The objective of the prospective, multicenter, single-group study was to evaluate safety, efficacy, and direct effects of the device on exposure to esophageal acid, quality of life, and the use of proton pump inhibitors (ppis).The authors performed a 5-year prospective, multicenter, single-group evaluation of magnetic sphincter device in patients, age range between 18 and 75 years with a = 6-month history of gastroesophageal reflux disease (gerd), partial response to daily ppis, and increased exposure to acid on ph monitoring.Data were available for 98 patients at year 1.The authors reported that the lower esophageal sphincter augmentation with a magnetic device may provide an alternative treatment for patients with incomplete symptomatic relief with ppi or reluctance to undergo fundoplication.Reported complications included serious adverse events (n=6) which required removal of the device during the 3-year follow-up; dysphagia (n=68%) which gradually reduced with time with a significant number of patients requiring repeated esophageal dilations; de novo esophagitis (n=?) which was developed to several patients with mild grades and 1 patient developed grade d but was completely asymptomatic.In conclusion, the clinical data clearly showed that the patients had heartburn symptoms despite ppi therapy, which resolved after magnetic augmentation.

• 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: 9103815
• MDR Text Key: 162644459
• Report Number: 3008766073-2019-00469
• 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: 08/28/2019

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
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/23/2019
• 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