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

Model Number	LXC13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Heartburn/Indigestion (1883)
Date of Event	12/07/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced recurrent gerd and related chest pain resulting in explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implantation occurred without issue (b)(6) 2015.Patient began experiencing moderate heartburn, and chest/throat pain on (b)(6) 2016.Patient had pains and plaques suggestive of candida on (b)(6) 2016 and was determined to have recurrent gerd.Uneventful device explant due to recurrent gerd and related chest pain on (b)(6) 2016.The device was found in the correct position/geometry at the time of removal.Patient underwent a hernia repair and fundoplication immediately after device explant.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• MDR Report Key: 6226591
• Report Number: 3008766073-2017-00002
• Device Sequence Number: 13637078
• Product Code: LEI
• UDI-Device Identifier: 00855106005141
• UDI-Public: 00855106005141
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2016

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: 01/21/2019
• Device Model Number: LXC13
• Device Lot Number: 7459
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2016
• Initial Report FDA Received Date: 01/05/2017
• 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; Other
• Patient Age: 57 YR
• Patient Weight: 91