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

Catalog Number LXMC16

Device Problems Device Appears to Trigger Rejection (1524); Patient Device Interaction Problem (4001)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 04/19/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 12/18/2023.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.Additional information received: patient identifier: (b)(6).(b)(6) medical center.Sex: male.Age (at time of consent): 72 years.Start date: (b)(6) 2023.Alert date: 03- may- 2023.Country of event: us.Model: lxmc16.Device lot number: 28359.Date of surgery: (b)(6) 2022.Adverse event term: dysphagia.Site awareness date: 19 apr 2023.End date: blank.Severity: mild.Is the adverse event serious? no.Relationship to study device: unlikely diagnostic imaging: yes.Drug therapy: yes.Outcome: not recovered/not resolved.If other, specify : blank: oral biopsies.Other surgical intervention : no: yes.Outcome : not recovered/not resolved: recovered/resolved.Updated log line 1 other intervention/treatment : no: yes.Other surgical intervention : yes: no.Other surgical intervention : no: yes"."relationship to study device: unlikely relationship to primary study procedure: unlikely ".There was no product complaint filed by our site for subject (b)(6).The linx remains implanted, thus no device to return.Prednisone was prescribed for dysphagia (ae #1), which subject had prior to implant.The primary md referred subject to ent (after marshmallow study was normal) for ¿concerns of oral phase dysphagia¿.Subject has history of oral surgery for dysplasia and return of ¿dysplastic like changes¿ and ¿pain that is likely secondary to scar tissue¿ from the previous surgery.The oral biopsies were not related to the linx device or implant." 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: dysphagia.Relationship to study device: unlikely.Relationship to primary study procedure: unlikely.

Manufacturer Narrative

(b)(4).Additional information received: date of dilation : blank - 08 feb 2024.Dilation performed : no, yes.Indicate type of dilation? : blank => mechanical.

Manufacturer Narrative

(b)(4).Additional information received: end date : blank- 20 feb 2024.Outcome : not recovered/not resolved.Recovered/resolved.

Manufacturer Narrative

(b)(4) date sent: 2/7/2024 additional information received: start date: blank alert date: (b)(6) 2024 country of event: us model: lxmc16 device lot number: 28359 date of surgery: (b)(6) 2022 adverse event term: dysphagia patient details patient identifier: (b)(6) sex: male age (at time of consent): 72 years additional event details site awareness date: (b)(6) 2024 end date: blank severity: blank is the adverse event serious? blank 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: blank relationship to primary study procedure: blank if related to the procedure, indicate which procedure the event is related to: blank intervention/treatment: none: no dilation performed: no indicate type of dilation? blank date of dilation: blank diagnostic intervention: no diagnostic imaging: no drug therapy: no observation: no linx explant: no other surgical intervention: no other intervention/treatment: no if other specify: blank outcome: blank according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated: blank did this event result in the patient¿s discontinuation of the study? blank is the adverse event serious? (if yes, check all that apply) : blank => no 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 => n/a outcome : blank => not recovered/not resolved relationship to study device : blank => unlikely severity : blank => mild relationship to study procedure : blank => unlikely.

• 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 ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 18344449
• MDR Text Key: 331055687
• Report Number: 3008766073-2023-00253
• 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,Followup
• Report Date: 03/27/2024

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 Catalogue Number: LXMC16
• Device Lot Number: 28359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 01/29/2024; 02/13/2024; 03/13/2024
• Supplement Dates FDA Received: 02/07/2024; 02/22/2024; 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male