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

Model Number LXMC14

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 12/14/2020.Event year: only event year known: 2020.The lot was not provided; therefore, the manufacturing record evaluation could not be performed.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? what is the lot number of the linx device? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? 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? were there any other contributing factors that led to the removal of the device other than the reported dysphagia? besides dysphagia, what was the reason for removal of the linx device? was the device found in the correct position/geometry at the time of removal?.

Event Description

It was reported that a linx device was explanted on (b)(6) 2020 due to dysphagia.

Manufacturer Narrative

(b)(4).Date sent: 1/6/2021.The dhr for lot 25638 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information was requested, and the following was obtained: what is the lot number of the linx device? 25638.When using the linx sizing device what technique was used to determine the size? pop plus 3.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids/immunization drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no.How severe was the dysphagia/odynophagia before intervention? not very severe, occasionally food would get stuck but the surgeon believes it was due to the patient not complying with the post-op diet instructions.Were there any intra-operative complications during the implant? no.Was there any hiatal or crural repair done at the same time as the implant? yes.Where there any other contributing factors that led to the removal of the device other than the reported dysphagia? no.Besides dysphagia, what was the reason for the removal of the linx device? n/a.Was the device found in the correct position/geometry at the time of removal? yes.

• 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: 11003333
• MDR Text Key: 221284262
• Report Number: 3008766073-2020-00200
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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 Expiration Date: 05/02/2023
• Device Model Number: LXMC14
• Device Catalogue Number: LXMC14
• Device Lot Number: 25638
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention