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 Pain (1994); Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 10/01/2019.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: crural closure improves outcomes of magnetic sphincter augmentation in gerd patients with hiatal hernia.Author: katrin schwameis, milena nikolic, deivis g.Morales castellano, ariane steindl, sarah macheck, m.Riegler, ivan kristo , barbara zorner & sebastian f.Schoppmann.Citation: scientific reports (2018) 8:7319; doi: 10.1038/s41598-018-24322-1.This retrospective study aimed to assess if hiatal repair in magnetic sphincter-augmentation (msa) patients significantly influences postoperative outcomes including reflux control and dysphagia rate.Between march 2012 and mar 2017, a total of 68 patients (n=46 males, n=22 females; median age of 45 years, range of 38-58) were included in the study.The patients were classified into 3 groups: ¿no hiatal hernia¿ (nhh) (n=16), ¿hiatal repair¿ (hr) (n=26) and ¿no hiatal repair¿ (nhr) (n=26) group.The surgical approach was laparoscopic in all cases.After mobilization of the esophagogastric junction, the adequate ring size was measured with the sizing tool and the magnetic device (linx reflux management system, ethicon) was wrapped around the lower end of the lower esophageal sphincter.Complaint included retrosternal pain (n=1 from hr group) and discomfort (n=1 from nhr group).The device was explanted in both patients due to the events.Additional complaint of rare difficulties swallowing solids (n = 14) and occasional difficulties with swallowing solids (n = 11) were reported.Magnetic lower esophageal sphincter (les) augmentation leads to significant gastrointestinal symptom relief, increased gerd-specific quality of life and good alimentary satisfaction with low perioperative morbidity rates.In patients with hiatal hernia, crural closure tends to result in better reflux control and gerd symptom relief compared to exclusive msa without increasing postoperative dysphagia rates.

• 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: 9141929
• MDR Text Key: 163599928
• Report Number: 3008766073-2019-00499
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2019

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
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/01/2019
• 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