MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Model Number LXMC14

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

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Speech Disorder (4415)

Event Date 12/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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: a trx_2012_01 subject id: 06-02-004.Lot number: 3964.Serial number: (b)(4).Event description: heartburn.Severity: moderate.Is the adverse event serious? no.Specify (if other is selected): not expected to have heartburn with linx implant per dr (b)(6).Relationship with study device: yes/probably/possibly.Outcome: ongoing at time of report.Event description: cough.Severity: mild.Is the adverse event serious? no.Risks of linx device implantation procedure and/or device: cough.Relationship with study device: yes/probably/possibly.Outcome: resolved.Medication: checked please specify: pantoprazole.Hiatal hernia repair: checked.Crural stitch: checked.Office/clinical visit: checked date: (b)(6) 2022.Event description: cough.Date resolved: (b)(6) 2022.Medication: checked please specify: pantoprazole.Event description: dysphagia.Ae status/outcome: resolved.Date resolved: (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.

Event Description

It was reported via clinical trial patient trx_2012_01 subject id: 06-02-004: event 1 - heartburn; event 2 ¿ cough; event 3 ¿ voice alteration; event 4 ¿ dysphagia.For all 4 events: relationship to the device/procedure: yes/probably/possibly.

Manufacturer Narrative

(b)(4); date sent: 9/29/2022.Investigation summary: 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.A manufacturing record evaluation was performed for the finished device 3964 batch number, and no non-conformances were identified.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15265179
• MDR Text Key: 305418106
• Report Number: 3008766073-2022-00165
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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: 09/29/2022

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 Expiration Date: 09/19/2016
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Device Lot Number: 3964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 08/22/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1