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

Model Number LXMC16

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Choking (2464)

Event Date 04/01/2022

Event Type  Injury  

Event Description

It was reported that a linx device was explanted due to dysphagia, exasperation, choking, coughing and burning pain.

Manufacturer Narrative

(b)(4).Event date: unknown, assumed 1st day of month that the event took place.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.No lot number was provided therefore a device history could not be done.Additional information was requested, and the following was obtained: do you have the linx product code? lmxc16.Do you have the lot number and serial number (if applicable)? no.Was the device explanted as scheduled (b)(6) 2022? yes.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? not sure.Please specify the symptoms the patient was experiencing prior to implant (gerd reflux, dysphagia, pain during eating, etc., )? gerd and had a gastric sleeve.Had the patient had any diagnostic testing done to address the symptoms they experienced while the device was implanted?don¿t know.If yes, what diagnostic testing was completed? n/a can you share the results of the diagnostic tests? n/a.Do they have an autoimmune disease? no.Has the patient been prescribed medication by a doctor (not over the counter medication)? not sure.If yes, what is the doctor prescribed medication? n/a.Are they currently taking steroids / immunization drugs? no.When using the linx sizing device what technique was used to determine the size? the normal sizing technique.How severe was the dysphagia/odynophagia before intervention? severe.Were there any intra-operative complications during implant? no.Was the device found in the correct position/geometry at the time of removal? yes.After implant, was the device initially effective in controlling reflux? don¿t know.When did the recurrent reflux begin? no recurrent reflux happened.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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
• Manufacturer Contact: orla o'mahony ; 4188 lexington avenue north; shoreview 55126
• MDR Report Key: 14345499
• MDR Text Key: 291284608
• Report Number: 3008766073-2022-00094
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2022

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: LXMC16
• Device Catalogue Number: LXMC16
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention