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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pocket Erosion (2013)

Event Date 07/07/2023

Event Type  Injury  

Event Description

It was reported via journal article: title: magnetic sphincter augmentation: paradigm change or just another device in the surgeon¿s toolbox? authors: tom r.Demeester.Citation: diseases of the esophagus (2023),36 1¿6.Https://doi.Org/10.1093/dote/doad026.The objective of this study is to confirm long terms safety and efficacy of the laparoscopic linx procedure at a single referral center.Between march 2007 and february 2014, a total of 140 patients who were implanted and had a minimum follow up of 6 years.The median follow-up was 9 years.The overall reported rate of the linx device erosion was less than 0.5%; with most events occurring within 4 year of the implant and managed effectively with endoscopic techniques and minimal morbidity.First, formal mediastinal dissection became routine practice; second new generation linx device was introduced for use in magnetic resonance up to 1.5t; and third, a new-generation sizer device for measuring the esophageal circumference was introduced.Reported complication includes erosion (n=?).In conclusion, based on the above results and the high levels of patient satisfaction, linx may represent a true paradigm shift that has the potential to fill the current therapy gap in gerd.

Manufacturer Narrative

(b)(4).Date sent: 4/11/2024.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: 19087744
• MDR Text Key: 339916404
• Report Number: 3008766073-2024-00064
• 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: 04/11/2024

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: 03/28/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention