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	03/23/2016
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) 2013.Patient underwent a 1.5t mri 2 weeks after implant; the implant is 0.7t conditional and considered unsafe in a 1.5t mri.Patient received a dilation approximately 5 months after implant.Uneventful device explant (b)(6) 2016.Linx device found in the correct position/geometry.After device removal, a second linx device was implanted (model lxmc15, lot number 9132, (b)(4)) without issue.

• 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: 5606394
• Report Number: 3008766073-2016-00032
• Device Sequence Number: 796330
• Product Code: LEI
• UDI-Device Identifier: 00855106005172
• UDI-Public: 00855106005172
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2016

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: 03/11/2017
• Device Model Number: LXC16
• Device Lot Number: 4511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2016
• Initial Report FDA Received Date: 04/25/2016
• 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: 55 YR
• Patient Weight: 78