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

Model Number LXMC15

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 12/16/2022

Event Type  Injury  

Event Description

It was reported that a linx was explanted.Implant date was (b)(6) 2021.Sales rep could not provide any other information at this time.

Manufacturer Narrative

(b)(4).Exact date of implant is unknown.Assumed 1st day of the month for implant day.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No lot number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: lot #? unknown.Does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies? unknown.Is the patient currently taking currently taking steroids / immunosuppressive drugs? unknown.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? unknown.Was there any hiatal or crural repair done at the same time as the implant? yes.Was mesh used at time of implant? no.What was the reason for removal of the linx device? dysphagia.At the time of removal, was the device found in the correct position/geometry at the time of removal? yes.Have the symptoms resolved since the device was explanted? unknown.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: 1/26/2023.Investigation summary: a separated washer was observed during the visual assessment.The washer was slightly bent outwards in the shape of a saddle with two welds tracks on the washer and also on the bead case where the washer was separated.This was likely due to forces applied during explant procedure.However, the separated washer didn¿t contribute to customer¿s experience.The visual analysis excepting the separated washer was consistent with an explanted device.Overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 16068088
• MDR Text Key: 306335801
• Report Number: 3008766073-2022-00253
• Device Sequence Number: 1
• Product Code: LEI
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

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 Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/16/2023
• Supplement Dates FDA Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention