MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT

Model Number LXMC16

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994)

Event Date 07/07/2021

Event Type  Injury  

Event Description

It was reported via clinical trial patient (b)(6) experience, post-operative pain.The event was not related to the study device.

Manufacturer Narrative

(b)94) the manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.Additional information received: diagnostic imaging: yes.Drug therapy: yes.Diagnostic imaging : yes => no.Drug therapy : yes => no.Awareness date : 29 jul 2021 => blank.Start date : (b)(6) 2021 => blank.Adverse event term : post-operative pain => blank.Outcome : recovered/resolved => blank.If the event is marked as being related to the procedure, indicate which procedure the event is related to : index => blank.Relationship to study device : not related => blank.Relationship to study procedure : possible => blank.Severity : mild => blank.Did this event result in the subject's discontinuation of the study?if yes, complete the study discontinuation form.: no => blank.Is the adverse event serious? (if yes, check all that apply) : no => blank.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? : n/a => blank.Patient identifier: (b)(6).The ohio state university.Sex: male.Age (at time of consent): 37 years.Alert date: 22- mar- 2023.Adverse event term: dysphagia.Site awareness date: 22 mar 2023.End date: (b)(6) 2022.Severity: moderate.Intervention/treatment: dilation performed: yes.Indicate type of dilation? mechanical.Date of dilation: (b)(6) 2022.Outcome: recovered/resolved.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? : blank => yes.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? : yes => 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.

Manufacturer Narrative

(b)(4).Date sent: 9/13/2023.Additional information received: 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? : indicate type of dilation? : blank mechanical.

• Brand Name: LINX 1.5 16 BEAD US
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 16681551
• MDR Text Key: 312689943
• Report Number: 3008766073-2023-00059
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• 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: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2022
• Device Model Number: LXMC16
• Device Catalogue Number: LXMC16
• Device Lot Number: 21200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Race: White