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: 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: post-operative dysphagia following magnetic sphincter augmentation for gastroesophageal reflux disease.Author/s: tsai c., kessler u., steffen r., zehetner j.Citation: surgical endoscopy.2019 apr; conference: 2019 scientific session of the society of american gastrointestinaland endoscopic surgeons, sages.United states.33 (supplement 1) :s336; http://dx.Doi.Org/10.1007/s00464.The aim of this study was to evaluate predictors of persistent post-operative dysphagia leading to intervention, as well as its impact on quality of life.From august 2015 to september 2018, 118 patients (m = 59, f = 59) with mean age was 50 years (r18-80) were included in the study.The authors reviewed the electronic medical records of all patients with gerd receiving a laparoscopic msa (linx reflux management system, torax medical) with posterior cruroplasty (pc).Post-operative dysphagia was present in 80 patients.Of them, 20 required balloon dilation for persistent dysphagia.Patients received a median of 1 dilation at a mean of 5.6 months (r1-13) after msa-pc.The msa device was explanted in two patients, while dysphagia resolved in 15 patients.Two patients have persistent symptoms and the remaining patient has insufficient follow-up.Compared to patients who did not require dilation, dilated patients were more likely to have atypical gerd symptoms pre-operatively.However, 92.3% of non-explanted patients requiring dilation reported an improved quality of life.In conclusion, although postoperative dysphagia is a common temporary side effect after msa-pc, and this is most commonly seen in patients with atypical gerd symptoms pre-operatively.Most cases of persistent dysphagia can be treated with a single balloon dilation.Despite requiring a dilation, the majority of patients still report an improved quality of life.

• 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: 9139308
• MDR Text Key: 163000165
• Report Number: 3008766073-2019-00486
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• 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: 09/17/2019

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: 09/17/2019
• 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