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

Model Number	LXC15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Heartburn/Indigestion (1883); Hernia (2240)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced ongoing gerd and a hiatal hernia leading to linx device explant.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including linx device implantation occurred without issue on (b)(6) 2014.Device explant due to ongoing gerd and hiatal hernia repair.Explant occurred without issue on (b)(6) 2017.The device was found in the correct position/geometry.After device removal, a paraesophageal hernia repair was performed and a second linx device (model: lxmc15, lot # 17189) was implanted on the "distal esophagus above the cardiac" without issue during the same surgery.

• 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: 7287210
• Report Number: 3008766073-2018-00024
• Device Sequence Number: 13909114
• Product Code: LEI
• UDI-Device Identifier: 00855106005165
• UDI-Public: 00855106005165
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/22/2018

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: 07/01/2018
• Device Model Number: LXC15
• Device Lot Number: 6401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/21/2018
• 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; Other
• Patient Age: 58 YR