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 05/24/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 3/16/2023.An analysis of the product could not be performed since a physical sample was not received for evaluation.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.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 provided:(b)(6).Sex: female.Age (at time of consent): 57 years.Start date: (b)(6) 2022.Alert date: 01- mar- 2023.Country of event: us.Model: lxmc16.Device lot number: 28492.Date of surgery: (b)(6) 2021.Adverse event term: epigastric pain related to esophageal dysmotility.Site awareness date: (b)(6) 2022.End date: (b)(6) 2022.Severity: moderate.Is the adverse event serious? no.Dilation performed: yes.Indicate type of dilation? mechanical.Date of dilation: (b)(6) 2022.Drug therapy: yes.Outcome: recovered/resolved.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 => no.No relationship to study device: causal relationship.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 Description

It was reported via clinical trial patient (b)(6) event: epigastric pain related to esophageal dysmotility.Relationship to study device: causal relationship.Relationship to primary study procedure: causal relationship.

Manufacturer Narrative

(b)(4); date sent: 4/12/2023.A manufacturing record evaluation was performed for the finished device batch number 28492, and no non-conformances were identified.

Manufacturer Narrative

(b)(6).Date sent: 6/21/2023.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?: no / n/a.Adverse event term: epigastric pain related to esophageal dysmotility/ dysphagia.

• 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: 16552468
• MDR Text Key: 311390263
• Report Number: 3008766073-2023-00039
• 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,Followup
• Report Date: 06/21/2023

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 Model Number: LXMC16
• Device Catalogue Number: LXMC16
• Device Lot Number: 28492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 04/12/2023; 06/13/2023
• Supplement Dates FDA Received: 04/12/2023; 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female