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

Model Number	LS12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	11/28/2016
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• MDR Report Key: 6209712
• Report Number: 3008766073-2016-00112
• Device Sequence Number: 16376006
• Product Code: LEI
• UDI-Device Identifier: 00855106005011
• UDI-Public: 00855106005011
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Expiration Date: 05/17/2016
• Device Model Number: LS12
• Device Lot Number: 3570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2016
• Supplement Report FDA Received Date: 03/16/2017
• 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; Disability
• Patient Age: 65 YR
• Patient Weight: 60