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

Model Number	LXC16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Dysphagia/ Odynophagia (1815); Heartburn/Indigestion (1883)
Date of Event	02/02/2018
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN 55126
• MDR Report Key: 7354684
• Report Number: 3008766073-2018-00042
• Device Sequence Number: 1291980
• Product Code: LEI
• UDI-Device Identifier: 00855106005172
• UDI-Public: 00855106005172
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Expiration Date: 12/19/2016
• Device Model Number: LXC16
• Device Lot Number: 5870
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Disability
• Patient Age: 46 YR