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

Model Number LXC16

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

Patient Problems Aspiration/Inhalation (1725); Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883)

Event Date 02/02/2018

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced ongoing gerd, mild dysphagia, and reflux with aspiration leading to linx device explant.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including hernia repair and linx device implantation occurred without issue on (b)(6) 2014.Patient arrived at the emergency department on (b)(6) 2017 with dyspnea, and was diagnosed with aspiration pneumonia and sepsis.Device explant due to ongoing gerd, dysphagia, and reflux with aspiration.Explant occurred without issue on (b)(6) 2017.A fundoplication was performed at the time of explant.During explant and then hiatal hernia repair with mesh, it was observed that "it appeared that the linx device had actually re-herniated posteriorly with some posterior stomach as well herniated through a recurrent defect posteriorly" and that "the esophagus and capsule for the linx had scarred into the mediastinum.".

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; 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: 7354684
• MDR Text Key: 102946596
• Report Number: 3008766073-2018-00042
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005172
• UDI-Public: 00855106005172
• 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: 02/19/2018

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: 12/19/2016
• Device Model Number: LXC16
• Device Lot Number: 5870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2012
• 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: 46 YR