MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Catalog Number LXMC14

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Dysphagia/ Odynophagia (1815); Discomfort (2330); Not Applicable (3189)

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The dhr for lot 22362 was reviewed.No ncs, reworks, or defects related to the product complaint were found.Additional information requested and received: what is the current status of the patient? she is healthy, recovered from this episode.Is the device still intact? it is.Did the patient receive a dilation? yes, she was dilated with the nasogastric tube when she was at the clinic, as reported.What diet is the patient currently on? normal postop diet.What does the surgeon believe is the cause of the dysphagia? he believes and is sure that this dysphagia was caused because of the great intake of food, larger than his recommendation.Did the dysphagia improve after the device was implanted initially? post op the patient didn`t suffer from dysphagia, only after this episode.Were there any intra-operative complications during implant? there were no complications during surgery.Was there any hiatal or crural repair done at the same time as the implant? yes, the surgeon repaired her hiatal hernia.What is the management plan? will the device be removed? no it won¿t be removed, she is recovering form surgery as expected, this episode was left behind.What diagnostic tests have been performed since you have experienced the symptoms you have stated above? control endoscopy.Have you received the diagnostic test results? if yes, are you able to share those test results with us? no, unfortunately we don¿t have access to the test.What treatment or treatments have been implemented? nasogastric tube was introduced to achieve the advancement of the food in addition to corticosteroids.

Event Description

It was reported an unexpected result from a patient that received a linx on (b)(6) 2019.At night the patient presented discomfort/difficulty to swallow food and went to hospital emergency, being hospitalized later.Initially there was suspicion of ingestion of a greater amount of food than the one suggested, resulting in an entrapment of food in the esophageal zone prior to the device location.A nasogastric tube was introduced to achieve the advancement of the food in addition to corticosteroids.The evolution of the case is being observed to follow with endoscopy and other steps.

• Brand Name: 1.5T LINX, 14B
• 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: 8535631
• MDR Text Key: 142622778
• Report Number: 3008766073-2019-00321
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2019

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: 07/25/2022
• Device Catalogue Number: LXMC14
• Device Lot Number: 22362
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1