MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5T 15 BEAD OUS; ANTI-REFLUX IMPLANT

Catalog Number LXM15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paresis (1998)

Event Date 06/14/2022

Event Type  Injury  

Event Description

It was reported that the patient was very satisfied with the linx implant but due to a stomach paresis it hast to be explanted.Patient has no dysphagia.

Manufacturer Narrative

(b)(4).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.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: did the stomach paresis resolve when the linx was removed? does the surgeon believe that the linx device is correlated to the stomach paresis? did the patient experience gas/bloating post-implant? did the patient receive any medical treatment for the stomach paresis? at the time of removal, was the device found in the correct position/geometry at the time of removal? 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: 8/25/2022.Investigation summary: a manufacturing record evaluation was performed for the finished device batch number a manufacturing record evaluation was performed for the finished device 27485 batch number, and no non-conformances were identified.Additional information was requested, and the following was obtained: did the stomach paresis resolve when the linx was removed? no, not in the last two month, but a control is planned.Does the surgeon believe that the linx device is correlated to the stomach paresis? yes, could be the reason, there is a temporal connection, the problems started soon after the implantation.Did the patient experience gas/bloating post-implant? no.- did the patient receive any medical treatment for the stomach paresis? yes at the time of removal, was the device found in the correct position/geometry at the time of removal? yes.

Manufacturer Narrative

(b)(4); date sent: 9/14/2022.Additional information was requested, and the following was obtained: what does the surgeon believe is the origin of the gastric paresis? does the surgeon believe there was issue with the vagus nerve during implant? answer = no further information are available.

• Brand Name: LINX 1.5T 15 BEAD OUS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: orla o'mahony ; 4188 lexington avenue north; shoreview 55126
• MDR Report Key: 14789938
• MDR Text Key: 295060386
• Report Number: 3008766073-2022-00129
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2022

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: LXM15
• Device Lot Number: 27485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 06/23/2022
• Supplement Dates Manufacturer Received: 08/18/2022; 09/12/2022
• Supplement Dates FDA Received: 08/25/2022; 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male