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

Model Number	LS13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Dysphagia/ Odynophagia (1815)
Date of Event	04/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia leading to endoscopic visualization of 2 device beads eroded into the esophageal lumen and subsequent explant of the entire linx device.The linx device was used as part of the anti-reflux procedure.- anti-reflux procedure including linx device implantation by dr.(b)(6) in 2013.- 4 device beads were observed endoscopically on (b)(6) 2017 on the posterior side of the esophageal lumen.- the linx device was explanted transgastrically in its entirety by dr.(b)(6) on (b)(6) 2017.- at a standard follow-up visit on (b)(6) 2017 the physician reported that the patient is doing well and has returned to their pre-implant status.
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia leading to endoscopic visualization of 2 device beads eroded into the esophageal lumen and subsequent explant of the entire linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including linx device implantation by dr.(b)(6) in 2013.The 4 device beads were observed endoscopically on (b)(6) 2017 on the posterior side of the esophageal lumen.The linx device was explanted transgastrically in its entirety by dr.(b)(6) on (b)(6) 2017.At a standard follow-up visit on (b)(6) 2017 the physician reported that the patient is doing well and has returned to their pre-implant status.

• 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: 6587993
• Report Number: 3008766073-2017-00054
• Device Sequence Number: 16388645
• Product Code: LEI
• UDI-Device Identifier: 00855106005028
• UDI-Public: 00855106005028
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2017

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 Model Number: LS13
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 06/28/2017
• 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: 45 YR
• Patient Weight: 76