MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Catalog Number LXMC17

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

Patient Problems Dysphagia/ Odynophagia (1815); Vomiting (2144)

Event Date 07/22/2021

Event Type  Injury  

Event Description

It was reported via clinical trial patient (b)(6) experience, dysphagia with vomiting.The event was not related to the study device.

Manufacturer Narrative

(b)(4).Date sent: 8/16/2023 investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.If the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device batch number 27477, and no non-conformances were identified.Additional information received: vidant medical center patient identifier: (b)(4), model: lxmc17 device lot number: 27477 date of surgery: (b)(6) 2021 adverse event term: dysphagia with vomiting severity: moderate sex: male age (at time of consent): 34 years intervention/treatment: none: no related relationship to primary study procedure: not related 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 severity : blank => moderate new log line 2 event details start date: (b)(6) 2022 alert date: (b)(6) 2023 country of event: us model: lxmc17 device lot number: 27477 date of surgery: (b)(6) 2021 adverse event term: dysphagia patient details patient identifier: (b)(6) sex: male age (at time of consent): 34 years additional event details site awareness date: (b)(6) 2023 end date: (b)(6) 2022 severity: mild 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: blank intervention/treatment: none: no dilation performed: yes indicate type of dilation? mechanical date of dilation: 28 jul 2022 diagnostic intervention: no diagnostic imaging: yes drug therapy: no observation: no linx explant: no other surgical intervention: no other intervention/treatment: no if other specify: blank outcome: recovered/resolved 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? no new log line 3 event details start date: 99 (b)(6) 2022 alert date: (b)(6) 2023 country of event: us model: lxmc17 device lot number: 27477 date of surgery: (b)(6) 2021 adverse event term: dysphagia patient details patient identifier: (b)(6) sex: male age (at time of consent): 34 years additional event details site awareness date: 25 jul 2023 end date: blank severity: mild 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: blank intervention/treatment: none: no dilation performed: yes indicate type of dilation? mechanical date of dilation: (b)(6) 2023 diagnostic intervention: no diagnostic imaging: yes drug therapy: no observation: no linx explant: no other surgical intervention: no other intervention/treatment: no if other specify: blank outcome: not recovered/not resolved according to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated: n/a did this event result in the patient¿s discontinuation of the study? no updated log line 2 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 updated log line 3 start date : 99 (b)(6) 2022 => un (b)(6) 2022 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: 10/4/2023.Additional information received: outcome : not recovered/not resolved : recovering/resolving.

• Brand Name: 1.5T LINX, 17 BEADS
• 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: 17555637
• MDR Text Key: 321226705
• Report Number: 3008766073-2023-00169
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• 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: 10/04/2023

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 Catalogue Number: LXMC17
• Device Lot Number: 27477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2020
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male