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

Event Date 12/03/2018

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.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? is the device available for return? if yes, please provide the contact name and address for the return kit.

Event Description

It was reported that a linx, lxmc16, removal took place on (b)(6) 2018 due to persistent dysphagia.Patient had been dilated two times after initial placement on (b)(6) 2018.No mesh used in original placement.Hiatal hernia was present and repaired at time of placement.

Manufacturer Narrative

(b)(4).Date sent: 01/09/2019.The dhr for lot 21200 was reviewed.No reworks, ncrs, or defects were found.Additional information received: this device will not be returning.

• 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: 8164604
• MDR Text Key: 130362697
• Report Number: 3008766073-2018-00223
• 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
• 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: 05/30/2022
• Device Catalogue Number: LXMC16
• Device Lot Number: 21200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 12/26/2018
• Supplement Dates FDA Received: 01/10/2019
• Patient Sequence Number: 1
• Patient Age: 29 YR