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); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Nausea (1970); Abdominal Distention (2601)

Event Date 05/19/2022

Event Type  Injury  

Event Description

It was reported via clinical trial patient (b)(4): (b)(6) event: dysphagea.Relationship to study device: possible relationship to primary study procedure: possible.

Manufacturer Narrative

(b)(4).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 received; country of event: (b)(6), model: lxmc15, device lot number: 25259, date of surgery: (b)(6) 2021, adverse event term: dysphagea, patient identifier: (b)(6), institute of esophageal and reflux surgery, sex: female, age (at time of consent): (b)(6), site awareness date: (b)(6) 2022, end date: blank, severity: moderate, dilation performed: yes, indicate type of dilation? mechanical, date of dilation: (b)(6) 2022, outcome: not recovered/not resolved, awareness date : (b)(6) 2021, start date : (b)(6) 2021, relationship to study device: possible relationship to primary study procedure: possible hiatal hernia was present at time of implant 3cm.Mesh was used.(b)(6), difficulty swallowing : true, painful swallowing : true, a lot of phlegm and can not vomit.Regurgitate often while eating.Heartburn, bloating and gassy, chest pain, change of voice, nausea.

Manufacturer Narrative

(b)(4), date sent: 7/5/2022.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device batch number 25259, and no non-conformances were identified.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.

Manufacturer Narrative

Pc-(b)(4).Date sent: 10/18/2022 g2: 2.Is report source foreign.The reported source was from usa.

Manufacturer Narrative

(b)(4).Date sent: 1/30/2024.Additional information received: start date : 10 jun 2021 => 19 may 2022.Updated log line 1: awareness date : 15 sep 2021 => 19 may 2022.

• 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: orla o'mahony ; 4188 lexington avenue north; shoreview 55126
• MDR Report Key: 14631577
• MDR Text Key: 293568106
• Report Number: 3008766073-2022-00116
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/30/2024

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 Expiration Date: 07/10/2023
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Device Lot Number: 25259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 07/05/2022; 10/18/2022; 01/20/2024
• Supplement Dates FDA Received: 07/05/2022; 10/18/2022; 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 79 KG