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

Model Number LXM16

Device Problem Defective Component (2292)

Patient Problem Chest Pain (1776)

Event Date 12/15/2017

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced pain and burning symptoms that lead to x-ray visualization of the linx device open.This led to explant of the linx device.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure including hernia repair and linx device implantation occurred without issue on (b)(6) 2016.-patient discharged from the hospital (b)(6) 2016, with "only slight levels of discomfort." -chest x-ray on (b)(6) 2017 visualized the device open.X-ray showed that the device was intact; however, bead-to-bead separation was larger than normal.-device explant due to the device opening occurred without issue on (b)(6) 2018.A fundoplication was performed at the time of explant.

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced pain and burning symptoms that lead to x-ray visualization of the linx device open.This led to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including hernia repair and linx device implantation occurred without issue on (b)(6) 2016.Patient discharged from the hospital (b)(6) 2016, with "only slight levels of discomfort." chest x-ray on (b)(6) 2017 visualized the device open.X-ray showed that the device was intact; however, bead-to-bead separation was larger than normal.Device explant due to the device opening occurred without issue on (b)(6) 2018.A fundoplication was performed at the time of explant.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• MDR Report Key: 7207422
• MDR Text Key: 97847392
• Report Number: 3008766073-2018-00012
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

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
• Device Operator: Physician
• Device Expiration Date: 11/06/2019
• Device Model Number: LXM16
• Device Lot Number: 9499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 02/01/2018
• Supplement Dates FDA Received: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 25 YR