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

Model Number LXMC14

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 08/14/2020.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information was requested, and the following was received: on what date did the implant take place? unknown.On what date did the explant take place? (b)(6) 2020.Lot #? unknown.Does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.- no.Is the patient currently taking currently taking steroids / immunization 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? ¿ unknown.Was mesh used at time of implant? - unknown.What was the reason for removal of the linx device? ¿ persistent dysphagia.At the time of removal, was the device found in the correct position/geometry at the time of removal? - unknown.Have the symptoms resolved since the device was explanted? - unknown.

Event Description

It was reported that the linx was successfully removed.No patient complications.

Manufacturer Narrative

(b)(4).Date sent: 9/2/2020.Investigation summary: device was returned in two sections.A washer was detached from a clasp bead.However, based on the additional information, the washer became loose during the explant procedure due to the applied forces.Hence, it didn't contribute to customer¿s experience.The visual analysis excepting the unseated 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.Additional information was requested, and the following was obtained: did the customer notice anything with the device prior to or during the explant procedure? no.We did not notice anything wrong with the device prior during procedure.Does the customer have a video of an explant procedure and could they share it with us? no.The reason for this request is that during the analysis, a loose washer was noted on a device.Based on the preliminary analysis, it seems that the washer came apart as part of explant procedure.Answer: that is most likely what happened.We tried to get the device apart without cutting the wire as to keep it intact as much as possible so there was so forces applied to the device trying to get it unclasped.We couldn't get it apart so he decided to cut the wire.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10408105
• MDR Text Key: 203483377
• Report Number: 3008766073-2020-00123
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Date Manufacturer Received: 08/25/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention