MAUDE Adverse Event Report: TORAX MEDICAL, INC. LINX REFLUX MANAGEMENT SYSTEM; ANTI-REFLUX IMPLANT

Model Number LXMC14

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

Patient Problems Dysphagia/ Odynophagia (1815); Ulcer (2274)

Event Date 02/01/2018

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced moderate dysphagia and a circumferential ulcer above the linx device leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including linx device implantation occurred without issue on (b)(6) 2017.Patient reported nausea and dysphagia on (b)(6) 2017 and was treated with a medrol dose pak on (b)(6) 2017.Patient reported nausea and acid burn in the mouth on (b)(6) 2017 and was treated with gaviscon and ppi.Patient experienced vomiting on (b)(6) 2017 and was treated with a medrol dose pak.Esophagogastroduodenoscopy (egd) with dilation on (b)(6) 2017 to treat dysphagia.A medrol dose pak was given at the time.Patient presented to er with dysphagia and chest pain "with eating anything" on (b)(6) 2018.Egd on (b)(6) 2018 showed an ulcer above the linx device.Device explant due to moderate dysphagia and a circumferential ulcer above the linx device occurred on (b)(6) 2018.Device was found in the correct position/geometry.Patient is "doing well" and her dysphagia has resolved as of (b)(6) 2018.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• Manufacturer (Section G): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN 55126
• Manufacturer Contact: tressa lauer ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 7303850
• MDR Text Key: 101241141
• Report Number: 3008766073-2018-00027
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2018

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: Physician
• Device Expiration Date: 03/10/2021
• Device Model Number: LXMC14
• Device Lot Number: 14225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 61 YR