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

Model Number LXMC14

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

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815); Vomiting (2144); Weight Changes (2607)

Event Date 10/07/2021

Event Type  Injury  

Event Description

It was reported that a linx device was explanted due to dysphagia, non-cardiac chest pain, regurgitation, weight loss, and coughing.

Manufacturer Narrative

(b)(4).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: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? 3/4/21 ph: composite demeester score normal at 3.1 in proximal sensor but demonstrates numerous episodes of reflux throughout the day from 6am-9pm; aet 5.2% 3/4/21 manometry: normal les relaxation with median irp 0.6 and fragmented peristalsis with dci 677.0 mmhg-cm-s, mean wave amplitude 44.9 mmhg 1/21/21 egd: 2cm hiatal hernia, la grade a esophagitis, gastric polyp, gastritis; pathology negative for intestinal metaplasia; positive for active esophagitis.What is the lot number of the linx device? - n/a.When using the linx sizing device what technique was used to determine the size? n/a.Did the patient have an autoimmune disease? n/a.Is the patient currently taking steroids / immunization drugs? not at this time but she did try prednisone prior to explant.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? n/a.How severe was the dysphagia/odynophagia before intervention? pretty severe given weight loss of 20+ lbs.Were there any intra-operative complications during implant? n/a.Was there any hiatal or crural repair done at the same time as the implant? n/a.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia, non-cardiac chest pain, regurgitation, weight loss, and coughing? n/a.Besides the reported dysphagia non-cardiac chest pain, regurgitation, weight loss, and coughing., what was the reason for removal of the linx device? n/a.Was the device found in the correct position/geometry at the time of removal? per egd 9/20/21 linx device impression in appropriate location.

Manufacturer Narrative

(b)(4).Date sent: 11/30/2021.Investigation summary: 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.No further investigation will be conducted on this complaint as the device is found to meet the specifications.Overall, no analysis conclusions relevant to the patient experience were found.

Manufacturer Narrative

(b)(4).Date sent: 11/18/2021.

• Brand Name: 1.5T LINX, 14B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 12711625
• MDR Text Key: 282516449
• Report Number: 3008766073-2021-00220
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2021

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: LXMC14
• Device Catalogue Number: LXMC14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 11/02/2021; 11/29/2021
• Supplement Dates FDA Received: 11/19/2021; 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention