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 11/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 received: prior to linx placement, did the patient have an egd, ph, and manometry studies done? not known.On what date did the implant take place? (b)(6) 2020.What is the lot number of the linx device? unknown.When using the linx sizing device what technique was used to determine the size? standard surgeon sizing technique by the surgeon.Did the patient have an autoimmune disease? not known.Is the patient currently taking steroids / immunization drugs? not known.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? not known.How severe was the dysphagia/odynophagia before intervention? not known - but patient requested removal.Were there any intra-operative complications during implant? not to my knowledge.Was there any hiatal or crural repair done at the same time as the implant? yes.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? patient was reportedly not following the eating/food size protocol.Besides dysphagia, what was the reason for removal of the linx device? patient request.Was the device found in the correct position/geometry at the time of removal? not known.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 that the patient was scheduled to have the linx device repositioned and prior to the procedure the patient elected to have the device removed.The patient was having dysphagia and this is the reason for having the device removed.

Manufacturer Narrative

(b)(4).Date sent: 01/06/2021.Device analysis: 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
• MDR Report Key: 11003071
• MDR Text Key: 221271666
• Report Number: 3008766073-2020-00197
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• 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
• Date Returned to Manufacturer: 12/15/2020
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention