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

Catalog Number LXMC17

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 08/26/2023

Event Type  Injury  

Event Description

It was reported via clinical trial patient (b)(6) experience, dysphagia.Relationship to study device: no.

Manufacturer Narrative

(b)(4).Date sent: 12/19/2023.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: start date: (b)(6) 2023.Alert date: (b)(6) 2023.Country of event: us.Model: lxmc17.Device lot number: 27824.Date of surgery: (b)(6) 2021.Adverse event term: dysphagia.Patient details.Patient identifier: (b)(6).Sex: female.Age (at time of consent): 70 years.Additional event details.Site awareness date: (b)(6) 2023.End date: (b)(6) 2023.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: index.Intervention/treatment: none: yes.Dilation performed: yes.Indicate type of dilation? mechanical.Date of dilation: (b)(6) 2023.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: recovered/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.Intervention/treatment.(check 'none' or all that apply)none : yes: no.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: 1/25/2024 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.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.A manufacturing record evaluation was performed for the finished device 27824 number, and no non-conformances related to the malfunction were identified.

• 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: 18356570
• MDR Text Key: 330890462
• Report Number: 3008766073-2023-00262
• 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: 01/25/2024

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: LXMC17
• Device Lot Number: 27824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2020
• 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: 70 YR
• Patient Sex: Female