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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Migration or Expulsion of Device (1395); Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Paresis (1998); Pocket Erosion (2013); Hernia (2240)

Event Date 11/01/2018

Event Type  Injury  

Event Description

Title: removing the magnetic sphincter augmentation device: operative management and outcomes authors: james m.Tatum, evan alicuben, nikolai bildzukewicz, kamran samakar, caitlin c.Houghton, john c.Lipham citation cite: surgical endoscopy (2019) 33:2663¿2669 https://doi.Org/10.1007/s00464-018-6544-y this is a retrospective review of patients undergoing msa removal from march 2009 to september 2017 in a single institution.Reason for removal, operative management, and short-term outcomes are reported.During the study, 435 msa devices were implanted all patients who underwent msa with the linx reflux management system (torax® medical, inc.Reported complications included dysphagia (n=9) , recurrent or persistent gerd (n=13) , secondary to erosion (n=2) and hiatal hernia (n=9) in conclusion msa removal when necessary can be accomplished through minimally invasive means.Repeat linx or fundoplication can be performed after removal, however may not be necessary in patients with removal for dysphagia.

Manufacturer Narrative

(b)(4).Date sent: 6/21/2023 this report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 17175082
• MDR Text Key: 317643370
• Report Number: 3008766073-2023-00111
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• 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
• Date Manufacturer Received: 06/14/2023
• 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
• Patient Outcome(s): Required Intervention