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

Catalog Number	LXMC15
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 7/22/2024.B3: only event year known: 2023.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.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: outcome: blank: not recovered/not resolved.Relationship to study device: blank: not related.Relationship to study procedure: blank not related.Updated log line 1: if event is serious and device related, according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated? no: n/a updated log line 1: if event is serious and device related, according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated? blank: no was the linx explant a result of an adverse event per protocol definitions? yes, if yes, choose the primary ae log line, start date and term: -esophageal spasms.Laparoscopic: yes.Resulted in medical or surgical intervention: yes.Dilation performed: yes.Indicate type of dilation? pneumatic drug therapy: yes, explant date nov 9, 2023 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 or Problem Description
It was reported via clinical trial patient trx_2018_01: 01443-011 experience, esophageal spasms, device explant.Relationship to study device: blank.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/13/2024.A manufacturing record evaluation was performed for the finished device lot number 27613, and no non-conformances were identified.Additional information received: updated "explant" notification.If yes, choose the primary ae log line, start date and term: #(b)(4) (b)(6) 2023-esophageal spasms blank.Was the linx explant a result of an adverse event per protocol definitions? yes no.Updated "explant" notification.If no, what was the reason for the explant? (check all that apply) participant had anxiety about implant: no yes.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/30/2025.Additional information: trx_2018_01 updated "explant" notification 01443-011.Updated: other: no: yes.Trx_2018_01 updated "explant" notification 01443-011.Updated: if other, specify: blank: the subject reported difficulty swallowing, painful swallowing and spasms from jackhammer esophagus.

• Brand Name: 1.5T LINX, 15B
• Common Device Name: 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: 19791956
• Report Number: 3008766073-2024-00113
• Device Sequence Number: 7252417
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2024
• Device Catalogue Number: LXMC15
• Device Lot Number: 27613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 08/07/2024; 06/26/2025
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/13/2024; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female