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

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 06/19/2023

Event Type  Injury  

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.

Event Description

It was reported via journal article: title: need for frequent dilations after magnetic sphincter augmentation: an assessment of associated factors and outcomes.Authors: inanc s.Sarici1 · sven e.Eriksson1 · ping zheng1 · toshitaka hoppo1,2 · blair a.Jobe1,2 · shahin ayazi1,2.Citation: surgical endoscopy 2023; https://doi.Org/10.1007/s00464-023-10197-5.This retrospective study of prospectively collected data aimed to characterize the population of patients who require frequent dilations for dysphagia within the first year after msa and to determine their outcomes.A total of 697 patients (62.7% female), aged 18¿89 with no history of prior foregut surgery, who underwent magnetic sphincter augmentation (msa) for gastroesophageal reflux disease (gerd) between 2013 and 2020 and who had at least 1-year follow-up were included in the study.Surgery was performed using linx implant (ethicon, johnson & johnson; shoreview, mn).Patients with dysphagia after msa who did not improve despite dietary recommendations were considered for endoscopic evaluation and dilation.Reported complications include dysphagia (n=187) required between 1 up to 5 dilations.In conclusion, the need for frequent dilations after msa is a marker for poor symptom control, dissatisfaction, and device removal.Patients with preoperative odynophagia, high les pressures, and poor esophageal motility should be counseled of their risk for these poor outcomes.

• 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: 19087609
• MDR Text Key: 339914253
• Report Number: 3008766073-2024-00063
• 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