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

Catalog Number LXMC15

Device Problem Migration (4003)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 01/03/2019

Event Type  Injury  

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.The dhr for lot 14308 was reviewed.No reworks, ncrs, or defects related to the product complaint were found.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.It was reported that the device was found to be slightly lower than where it should have been.How was this migration of the device diagnosed (chest x-ray, esophageal line at explant)? please explain.We are looking for a time timeline of the event: when did the dysphagia start? when was the migration of the device diagnosed (prior to the dysphagia or after)? when did the patient have the gastric poem? when the device was explanted could it be confirmed that device was in the correct position/geometry? 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? does the surgeon believe that the dysphagia was contributed to by the movement of the device? 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?.

Event Description

It was reported that there was a linx device removal due to the patient having dysphagia.The device was found to be slightly lower than where it should¿ve been.The case was completed with the patient being converted to a toupet.This patient underwent a gastric poem a week after linx implantation.The doctor was thinking this instrumentation during the important encapsulation period could¿ve lead to this.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: response: i¿ve followed up with the surgeon on three occasions now and no other information is available.

• 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: 8261655
• MDR Text Key: 133712787
• Report Number: 3008766073-2019-00259
• 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: 01/03/2019

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: 03/15/2021
• Device Catalogue Number: LXMC15
• Device Lot Number: 14308
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 01/22/2019
• Supplement Dates FDA Received: 01/24/2019
• Patient Sequence Number: 1