MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 13B; ANTI-REFLUX IMPLANT

Catalog Number LXMC13

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

Patient Problems Dysphagia/ Odynophagia (1815); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only event year known: 2018.As a lot was not provided, a device history 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.Is the lot number available for the lxmc13? on what date did the explant take place? 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? what is the current status of the patient?.

Event Description

It was reported that the device was implanted on a female patient one month ago and she was having persistent dysphagia.He mentioned he tried her on po steroids for one week along with a course of iv steroids and he dilated her esophagus with no improvement in symptoms.He mentioned she had a previous history of a cervical spine injury with a fusion which may be leading to some dysmotility.He also mentioned her motility study prior to linx showed 80% effective swallows.Patient is now an inpatient and unable to eat so he made decision to remove linx device.Linx 13 device was removed without difficulty or patient complications.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: is the lot number available for the lxmc13? 18883 - on what date did the explant take place? (b)(6) 2018.- 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? n/a.- did the dysphagia improve after the device was implanted initially? n/a.- were there any intra-operative complications during implant? no.- was there any hiatal or crural repair done at the same time as the implant? yes - what was the reason for removal of the linx device? dysphagia due to poor.Esophageal contraction.Patient had cervical fusion in the past, that may have caused esophageal dysmotility that was not really evidenced prior to surgery.- was the device found in the correct position/geometry at the time of removal? yes.

Manufacturer Narrative

(b)(4).Date sent: 03/27/2019.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 of lot 18883 was reviewed.No defects, ncrs, or reworks were found.

• Brand Name: 1.5T LINX, 13B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8164237
• MDR Text Key: 130342954
• Report Number: 3008766073-2018-00221
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005332
• UDI-Public: 00855106005332
• 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,Followup
• Report Date: 12/04/2018

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 Expiration Date: 01/25/2022
• Device Catalogue Number: LXMC13
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 01/09/2019; 02/05/2019; 03/21/2019
• Supplement Dates FDA Received: 01/11/2019; 02/26/2019; 03/27/2019
• Patient Sequence Number: 1