MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5T 17 BEAD OUS; ANTI-REFLUX IMPLANT

Catalog Number LXM17

Device Problems 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); Muscular Rigidity (1968); Vomiting (2144); Weight Changes (2607)

Event Date 05/17/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 11/20/2023.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information was requested, and the following was obtained: was there any hiatal or crural repair done at the same time as the implant? yes.Was mesh used at time of implant? no.At the time of removal, was the device found in the correct position/geometry at the time of removal? yes.Have the symptoms resolved since the device was explanted? unknown.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 that a linx has been explanted due to the patients request.Patient has a low bm, post sleeve.Functional stenosis, but pulp swallowing was ok symptoms: feeling of tightness, vomiting, weight loss.

Manufacturer Narrative

(b)(4).Date sent: 12/1/2023.Mso stated the patient suffered from dysphagia.

Manufacturer Narrative

(b)(4).Date sent: 1/4/2024.A manufacturing record evaluation was performed for the finished device 28022 number, and no non-conformances related to the malfunction were identified.

• Brand Name: LINX 1.5T 17 BEAD OUS
• 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: 18169681
• MDR Text Key: 328533848
• Report Number: 3008766073-2023-00231
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2024

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: LXM17
• Device Lot Number: 28022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 11/20/2023; 01/04/2024
• Supplement Dates FDA Received: 12/01/2023; 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention