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

Model Number LXMC13

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

Patient Problems Dysphagia/ Odynophagia (1815); Regurgitation (2259)

Event Date 02/23/2018

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia and "persistent issues with saliva and regurgitation" leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including hernia repair with mesh and linx device implantation occurred without issue on (b)(6) 2017.Three dilations were performed.Device explant due to dysphagia and "persistent issues with saliva and regurgitation" occurred without issue on (b)(6) 2018.Device was found in the correct position/geometry.On (b)(6) 2018, the patient's husband informed the physician that the patient was experiencing the same pain that they had been experiencing prior to linx device implant.The physician is monitoring the patient.

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia and "persistent issues with saliva and regurgitation" leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including hernia repair with mesh and linx device implantation occurred without issue on (b)(6) 2017.Three dilations were performed.Device explant due to dysphagia and "persistent issues with saliva and regurgitation" occurred without issue on (b)(6) 2018.Device was found in the correct position/geometry.On (b)(6) 2018, the patient's husband informed the physician that the patient was experiencing the same pain that they had been experiencing prior to linx device implant.The physician is monitoring the patient.-physician reports that the patient "is better.Much less dysphagia" as of (b)(6) 2018.

Manufacturer Narrative

Updated b5 to include patient status.Updated b6 to include device analyisis.Updated h6 to include method codes 10.84, and 3354.Updated report date.

• 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
• MDR Report Key: 7382423
• MDR Text Key: 103856634
• Report Number: 3008766073-2018-00048
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

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: 04/19/2021
• Device Model Number: LXMC13
• Device Lot Number: 14615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 04/03/2018
• Supplement Dates FDA Received: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 67 YR