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

Catalog Number LXMC16

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); No Code Available (3191)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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? did the dysphagia improve after the device was implanted initially? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? 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 the patient had an implant on (b)(6) 2017 and started experiencing epigastric pain on (b)(6) 2017.The patient had an explant on (b)(6) 2018.The entire device was removed, and a hiatal hernia repair was performed.No device was replaced.There was very thin scar tissue but no other observations.Implant occurred at a different hospital.

Manufacturer Narrative

(b)(4).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 dhr could not be performed, as the lot number is unknown.

Manufacturer Narrative

(b)(4).Date sent: 01/24/2019.Additional information was requested, and the following was obtained: did the patient have an autoimmune disease? n/a.Is the patient currently taking steroids / immunization drugs? patient was on steroids (b)(6) 2018 to for dysphasia (short course).Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? not identified in patient chart.How severe was the dysphagia/odynophagia before intervention? patient complained of epigastric pain while implanted with linx, especially when lying down.Did the dysphagia improve after the device was implanted initially? patient had office visit (b)(6) 2019 with (b)(6).She is still complaining of abdominal pain near epigastric region and is unable to burp.Patient did not follow the recommended diet post-surgery.Were there any intra-operative complications during implant? none noted was there any hiatal or crural repair done at the same time as the implant? yes, hiatal hernia repair was done.What was the reason for removal of the linx device? continuous epigastric pain and experiences some heartburn symptoms.Was the device found in the correct position/geometry at the time of removal? yes.

• 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: 8220460
• MDR Text Key: 132205109
• Report Number: 3008766073-2019-00233
• 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,Followup
• Report Date: 12/11/2018

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 Catalogue Number: LXMC16
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/26/2018
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 01/10/2019; 03/26/2019
• Supplement Dates FDA Received: 01/24/2019; 04/04/2019
• Patient Sequence Number: 1