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 Abdominal Pain (1685); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Vomiting (2144); No Code Available (3191)

Event Date 10/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unknown.As a lot/batch was not provided, a device history could not be performed.Lxmc13- no lot available.Original procedure on (b)(6) 2018 - at different hospital.Patient had complaint of esophageal spasm, dysphagia, chest pain/tightness, vomiting and abdominal pain.Patient went through multiple dilatation procedures to enable her to eat normal foods, patient could not deal with the inability to swallow and the pain which resulted in the explant of the device.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 any pre-existing dysphagia or other conditions (other than gerd) pre-implant? 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? was mesh used at time of implant? was the device found in the correct position/geometry at the time of removal? if not, please describe observations.Please explain any other notable observations during explant.Has the patient¿s symptoms improved or resolved since the device was explanted?.

Event Description

It was reported that post implant procedure that facility had explanted a linx device this am.There were no patient consequences reported.No further information provided.

• Brand Name: 1.5T LINX, 13B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: milt garrett ; 4188 lexington avenue north; shoreview, MN
• MDR Report Key: 8061695
• MDR Text Key: 126934848
• Report Number: 3008766073-2018-00203
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2018

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: LXMC13
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1