MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX 1.5 16 BEAD US; ANTI-REFLUX IMPLANT

Model Number LXMC16

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 8/12/2020 date of event: only event year is known: 2020.No lot or batch number was provided therefore a device history could not be done.Additional information was requested and the following was received: patient has no auto immune.There was a hiatal hernia repair.Patient was put on steroids 10mg for two days and on tapering dosage.No abnormalities when removing device.Device was totally intact.On what date did the explant take place? (b)(6) 2020.What is the product code for the linx device that was removed? what is the lot number of the linx device? when using the linx sizing device what technique was used to determine the size? yes.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunization drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? hiatal hernia repair.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? no.What was the reason for removal of the linx device? dysphagia.Was the device found in the correct position/geometry at the time of removal?.

Event Description

It was reported that the device will be explanted on (b)(6) 2020 due to dysphagia.

Manufacturer Narrative

(b)(4).Date sent: 08/25/2020.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.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

• Brand Name: LINX 1.5 16 BEAD US
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10396173
• MDR Text Key: 202628301
• Report Number: 3008766073-2020-00121
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• 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: 06/16/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: LXMC16
• Device Catalogue Number: LXMC16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 08/25/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention