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

Catalog Number LXMC15

Device Problem Insufficient Information (3190)

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

Event Date 11/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.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.Additional information was requested, and the following was obtained: did the explant procedure take place? yes; if yes, on what date was the band explanted? (b)(6) 2018; do you have the linx product code (model number), lot number not available and serial number (not applicable)? lxmc15; what was the reason for removal of the linx device (e.G.No issue - patient requested removal, ongoing dysphagia, ongoing gerd symptoms, etc.)? if dysphagia, how severe was the dysphagia/odynophagia before intervention (mild, moderate or severe)? did the dysphagia improve after the device was implanted initially? some dysphagia from time of implantation; did the patient have an autoimmune disease? no; is the patient currently taking steroids / immunization drugs? no; when was the linx device implanted? (b)(6) 2018; 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; was the device found in the correct position/geometry at the time of removal? yes; was a new linx placed after this one was removed? no; what is the current patient status? patient is doing well post linx removal per the surgeon.Comments: patient with poor teeth and may not have followed the postop eating regimen as instructed.

Event Description

It was reported that a linx removal took place on 11/7/2018.

Manufacturer Narrative

(b)(4).Device has not been released by the patient and cannot be shipped back.If that changes then it will be shipped back.

• 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: 8124857
• MDR Text Key: 129077252
• Report Number: 3008766073-2018-00215
• 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: 11/20/2018

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: LXMC15
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 12/04/2018
• Supplement Dates FDA Received: 12/05/2018
• Patient Sequence Number: 1
• Patient Weight: 73