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

Model Number LXMC15

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date: only event year known: 2020.Device remains implanted.No lot number was provided therefore a device history could not be done.Additional information received: the doctor has recommended a couple more attempts at dilation before considering any removal.Additional information was requested, and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? what is the lot number of the linx device? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? were there any intra-operative complications during implant? were there any other contributing factors that led to the er visit other than the reported dysphagia? if an x-ray was taken at the time of the er visit/hospitalization, or during the dilation, was the device found in the correct position/geometry? answers = there are no new additional details available at this time.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the patient presented to the er with severe dysphagia.They administered iv steroids, incurred a gi scope and device dilation.They were discharged with a medrol dose pack.The patient may have the device explanted after consultation with a physician.

Manufacturer Narrative

(b)(4).Date sent: 02/02/2021.Additional information was obtained: the surgeon did a dilation under fluoro (date unknown) to alleviate the patient¿s symptoms.The patient still complaining of excessive dysphagia and has requested to have the device removed.Explant date has not been set.Additional information was requested, and the following was obtained: can we please ask that when the explant date is scheduled? no explant date has been scheduled at this time that ethicon rep is aware of.The surgeon has not responded to requests for more information.

• 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: 10819623
• MDR Text Key: 217181801
• Report Number: 3008766073-2020-00168
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention