MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Catalog Number	LXMC14
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Insufficient Information (4580)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical trial patient (b)(6) experience, dysphagia and "fullness" in throat.Relationship to study device: possible.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/14/2024 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: start date: 14 mar 2024 alert date: 09- may- 2024 country of event: us model: lxmc14 device lot number: 24939 date of surgery: (b)(6) 2021 adverse event term: dysphagia and "fullness" in throat patient details patient identifier: (b)(6) sex: female age (at time of consent): 61 years additional event details site awareness date: 2 may 2024 end date: 16 apr 2024 severity: moderate is the adverse event serious? no death: no date of death: blank life-threatening illness or injury: no permanent impairment of a body structure or a body function: no required in-patient hospitalization or prolongation of existing hospitalization: no admission date: blank discharge date: blank resulted in medical or surgical intervention: no led to fetal distress, fetal death or a congenital abnormality or birth defect: no relationship to study device: possible relationship to primary study procedure: possible if related to the procedure, indicate which procedure the event is related to: reimplant intervention/treatment: none: no dilation performed: yes indicate type of dilation? pneumatic date of dilation: 1 apr 2024 diagnostic intervention: no diagnostic imaging: yes drug therapy: no observation: no linx explant: no other surgical intervention: no other intervention/treatment: yes if other specify: egd to ascertain position of implant outcome: recovered/resolved according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated: no did this event result in the patient¿s discontinuation of the study? no log line 1 updated 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.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/20/2024.Additional information received: egd to ascertain position of implant: egd to ascertain position of implant, esophagram.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/20/2024.Additional information received: if the event is marked as being related to the procedure, indicate which procedure the event is related to : reimplant index.A manufacturing record evaluation was performed for the finished device lot number 24939, and no non-conformances were identified.

• Brand Name: 1.5T LINX, 14B
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 19308992
• Report Number: 3008766073-2024-00085
• Device Sequence Number: 17870298
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2023
• Device Catalogue Number: LXMC14
• Device Lot Number: 24939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 06/18/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 05/20/2024; 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female