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

Model Number LXMC17

Device Problems Device Appears to Trigger Rejection (1524); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Hypoxia (1918)

Event Date 08/01/2022

Event Type  malfunction  

Event Description

It was reported via clinical trial patient (b)(6) experience, decreased oxygen level.Relationship to study device: not related.

Manufacturer Narrative

(b)(4).Date of event: exact day unknown.Assume the first day of the month the event took place.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: patient identifier: (b)(6).(b)(6) medical center.Sex: female.Age (at time of consent): 56 years.Country of event: us.Model: lxmc17.Device lot number: 28493.Date of surgery: (b)(6) 2022.Adverse event term: decreased oxygen level.Site awareness date: (b)(6) 2022.End date: (b)(6) 2022.Severity: mild.Is the adverse event serious? yes.Required in-patient hospitalization or prolongation of existing hospitalization: yes.Admission date: (b)(6) 2022 discharge date: (b)(6) 2022.Other intervention/treatment: yes.If other specify: increased oxygen delivery methods, pulmonary toilet.Outcome: recovered/resolved, relationship to study procedure : blank - possible.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: 9/21/2022 b2.

Manufacturer Narrative

(b)(4).Date sent: 10/5/2022 additional information received: relationship to study procedure : possible => probable awareness date : (b)(6) 2022 : (b)(6) 2022 start date : (b)(6) 2022 : (b)(6) 2022 admission date : blank : (b)(6) 2022 discharge date : blank: (b)(6) 2022 required in-patient hospitalization or prolongation of existing hospitalization : no : yes.Is the adverse event serious? (if yes, check all that apply) : no : yes.

Manufacturer Narrative

(b)(4); date sent: 10/27/2022.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device 28493 batch number, and no non-conformances were identified.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.Additional information received: end date : (b)(6) 2022.

Manufacturer Narrative

(b)(4).Additional information received: relationship to study device: probable.Relationship to primary study procedure: probable.Diagnostic imaging: yes.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.Diagnostic imaging : no = yes.Outcome : blank = not recovered/not resolved.Relationship to study procedure : blank = probable.

Manufacturer Narrative

(b)(4).Date sent; 6/15/2023.Additional information received: end date : blank => 01 feb 2023.Outcome : not recovered/not resolved => recovered/resolved.Adverse event term: dysphagia.Relationship to study device: probable.

• 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: orla o'mahony ; 4188 lexington avenue north; shoreview 55126 ; 329348013
• MDR Report Key: 15462039
• MDR Text Key: 306421272
• Report Number: 3008766073-2022-00188
• 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,Followup,Followup,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LXMC17
• Device Catalogue Number: LXMC17
• Device Lot Number: 28493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 09/21/2022
• Supplement Dates Manufacturer Received: 09/07/2022; 09/22/2022; 10/27/2022; 01/03/2023; 06/06/2023
• Supplement Dates FDA Received: 09/21/2022; 10/05/2022; 10/27/2022; 01/18/2023; 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female