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

Model Number LXMC15

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Headache (1880); Muscle Spasm(s) (1966); Pain (1994); No Code Available (3191)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 9/21/2020.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.The dhr for lot 22895 was reviewed.No defects, ncrs, or reworks related to the product complaint were found.Additional information was requested, and the following was obtained: the patient went through an mri then experienced symptoms of dysphagia and having spasms in the throat, pain in the chest and severe headaches.Surgeon has not been able to confirm the mri strength with facility that conducted the mri.Prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? yes.On what date did the implant take place? (b)(6) 2019.What is the lot number of the linx device? 22895.When using the linx sizing device what technique was used to determine the size? measuring wand.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)? how severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? no.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? the patient states he was having spasms in the throat, pain in the chest and severe headaches.Besides dysphagia, what was the reason for removal of the linx device? the patient states he was having spasms in the throat, pain in the chest and severe headaches.Was the device found in the correct position/geometry at the time of removal? yes.

Event Description

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

Manufacturer Narrative

(b)(4).Date sent: 10/27/2020.Additional information received: the device was confirmed to have gone through a 1.5t mri machine per the doctor.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: 10559873
• MDR Text Key: 207713326
• Report Number: 3008766073-2020-00145
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2022
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Device Lot Number: 22895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Date Manufacturer Received: 10/01/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention