MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Model Number LXMC15

Device Problems Device Appears to Trigger Rejection (1524); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Pain (1994); Hernia (2240)

Event Date 10/25/2021

Event Type  Injury  

Event Description

A male patient with a previous history of gerd and hiatal hernia had a linx device implanted on (b)(6) 2017.Records provided indicate four years after implant, patient experienced pain while undergoing an mri following which he developed recurrent gerd symptoms.Patient had radiology and esophagram in 2021 indicating the patient had a hiatal hernia and the device appeared discontinuous.The device was removed in (b)(6) 2021 by the implant surgeon.Medical records, including implant and explant operative notes and lot number are provided.Operative note indicates device was removed successfully and intraoperative egd revealed ¿no obvious injury to the esophagus or stomach.¿ no records following surgery are provided at this time.

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device batch number 16143, and no related nonconformances were identified.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: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 16724369
• MDR Text Key: 313151967
• Report Number: 3008766073-2023-00062
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2021
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Device Lot Number: 16143
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male