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 Code	Heartburn/Indigestion (1883)
Date of Event	03/16/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced ongoing gerd leading to linx device explant.The linx device was used as part of the anti-reflux procedure.-uneventful anti-reflux procedure and device implant on (b)(6) 2015.-uneventful device explant on (b)(6) 2017 due to ongoing gerd symptoms.Device was noted as tilted downwards anteriorly and 1-2 cm below the gastroesophageal junction; investigation found that the surgeon believed he misplaced the linx device during implant.Removal surgery included a hernia repair.-after device removal, a hiatal hernia repair was performed and a second linx device (model: lxmc16, lot # 8178, serial # (b)(4)) was implanted 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: 6493342
• Report Number: 3008766073-2017-00042
• Device Sequence Number: 1627551
• Product Code: LEI
• UDI-Device Identifier: 00855106005172
• UDI-Public: 00855106005172
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2017

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: 10/31/2017
• Device Model Number: LXC16
• Device Lot Number: 5477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2017
• Initial Report FDA Received Date: 04/14/2017
• 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: 50 YR
• Patient Weight: 85