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

Model Number LS12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Erosion (1750)

Event Date 11/28/2016

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure a patient experienced gradual developing dysphagia symptoms leading to endoscopic visualization of seven linx device beads within the esophageal lumen on (b)(6) 2016.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure and linx device implantation occurred without issue on (b)(6) 2013.-x-ray examination due to dysphagia symptoms on (b)(6) 2016 showed the linx device in an "odd position" and an esophagogastroduodenoscopy (egd) performed also on (b)(6) 2016 confirmed at least seven linx device beads in the esophageal lumen.-patient was reported as able to swallow soft foods and liquids at time of erosion discovery.-uneventful endoscopic explant of 6 linx device beads on (b)(6) 2016.The physician plans to laparoscopically remove the remainder of the device at a later date.-patient is doing well and only complained of a sore throat after surgery.

Event Description

Following a laparoscopic anti-reflux procedure a patient experienced gradual developing dysphagia symptoms leading to endoscopic visualization of seven linx device beads within the esophageal lumen on (b)(6) 2016 and subsequent device explant.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implantation occurred without issue on (b)(6) 2013.X-ray examination due to dysphagia symptoms on (b)(6) 2016 showed the linx device in an "odd position" and an esophagogastroduodenoscopy (egd) performed also on (b)(6) 2016 confirmed at least seven linx device beads in the esophageal lumen.Patient was reported as able to swallow soft foods and liquids at time of erosion discovery.Uneventful endoscopic explant of 6 linx device beads on (b)(6) 2016.Patient is doing well and only complained of a sore throat after surgery.Uneventful hernia repair and laparoscopic explant of remaining 6 linx device beads on (b)(6) 2017.Patient doing well on (b)(6) 2017; prescribed protonix and zantac to manage reflux.

• 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
• Manufacturer (Section G): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN 55126
• Manufacturer Contact: jessica ahlborn ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 6209712
• MDR Text Key: 63407991
• Report Number: 3008766073-2016-00112
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005011
• UDI-Public: 00855106005011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

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
• Device Operator: Physician
• Device Expiration Date: 05/17/2016
• Device Model Number: LS12
• Device Lot Number: 3570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 65 YR
• Patient Weight: 60