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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Vomiting (2144)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only event year known: 2020; captured as citation date.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.The lot number was not provided; therefore, a manufacturing record evaluation could not be performed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported via journal article: title: safety and efficacy of an implantable device for management of gastroesophageal reflux in lung transplant recipients author: samantha e.Halpern, aryaman gupta, vignesh raman, oliver k.Jawitz, ashley y.Choi, hai salfity, john c.Haney, jacob a.Klapper, matthew g.Hartwig citation: not reported doi: not reported this study is consisted of 14 lung transplant recipients (ltx) with gerd who underwent treatment with linx reflux management system (msa device) (ethicon) between 2017-2019.Persistent dysphagia requiring device dilation (n=3), subsequent device explant (n=2) at day 77 and 448 after implantation, vomiting (n=unknown) and throat pain (n=unknown) were the reported complications.Ltx recipients who underwent linx device implantation demonstrated a significant decrease in esophageal acid exposure time without major complications up to 12 months post-operatively.Use of the linx msa is a safe and effective method for management of post-ltx gerd in this highrisk population.

Manufacturer Narrative

(b)(4).Date sent: 3/17/2021.H10: this report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 11504791
• MDR Text Key: 241615467
• Report Number: 3008766073-2021-00039
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

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: 03/17/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 03/17/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention