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 Code	Heartburn/Indigestion (1883)
Date of Event	07/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient reported ongoing gerd symptoms leading to linx device explant.The linx device was used as part of the anti-reflux procedure.Uneventful anti-reflux procedure including hernia repair and linx device implant on (b)(6)2015 by dr.(b)(6).Prior to device removal on (b)(6) 2017, the patient had an egd with balloon dilation under fluro to 20mm.Uneventful device explant on (b)(6) 2017 by dr.(b)(6) due to ongoing gerd symptoms; patient was also experiencing burning in throat, regurgitation, and chest/epigastric pain.Device was found encapsulated with minimal adhesions noted and "easily identified and loose".Linx device found in the correct position/geometry.At the time of device explant, the patient received a fundoplication.

• 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: 6826532
• Report Number: 3008766073-2017-00100
• Device Sequence Number: 518757
• Product Code: LEI
• UDI-Device Identifier: 00855106005141
• UDI-Public: 00855106005141
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2017

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: 09/24/2017
• Device Model Number: LXC13
• Device Lot Number: 5282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 08/29/2017
• 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: 63 YR