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

Catalog Number LXMC15

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

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

Event Date 11/23/2018

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.As a lot/batch 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.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 device was ex-planted due to prolonged dysphagia."patients" current condition is good.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Date sent: 05/02/2019.Corrected data: device for this complaint was not received.Additional information received: it was confirmed that the device returned was not associated to this complaint.The device for this complaint will not be returned.

• 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: 8137325
• MDR Text Key: 129458687
• Report Number: 3008766073-2018-00216
• 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,Followup
• Report Date: 11/23/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 01/10/2019; 04/23/2019
• Supplement Dates FDA Received: 01/31/2019; 05/02/2019
• Patient Sequence Number: 1
• Patient Age: 44 YR