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

Model Number LXMC15

Device Problems Device Appears to Trigger Rejection (1524); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); No Code Available (3191)

Event Date 10/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information was requested, and the following was received: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? unknown.On what date did the implant take place? unknown.What is the lot number of the linx device? unknown.When using the linx sizing device what technique was used to determine the size? unknown.Did the patient have an autoimmune disease? unknown.Is the patient currently taking steroids / immunization drugs? unknown.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? unknown.How severe was the dysphagia/odynophagia before intervention? unknown.Were there any intra-operative complications during implant? unknown.Was there any hiatal or crural repair done at the same time as the implant? unknown were there any other contributing factors that led to the removal of the device other.Than the reported dysphagia? unknown.Besides dysphagia, what was the reason for removal of the linx device? unknown.Was the device found in the correct position/geometry at the time of removal? unknown.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

Event Description

It was reported that the linx was explanted due to persistent dysphasia.Case was successfully completed.

Manufacturer Narrative

(b)(4).Date sent: 12/01/2020.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: 10842987
• MDR Text Key: 216344389
• Report Number: 3008766073-2020-00179
• 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: 10/30/2020

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?: Yes
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 11/30/2020
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1