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

Model Number	LXC12
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	12/10/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia leading to visualization of linx device beads within the esophageal lumen.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implantation reported as (b)(6) 2014.Endoscopy completed (b)(6) 2015 due to dysphagia revealed a bead (titanium encased magnets) to be visible in the esophagus.The linx device was intact.Endoscopic removal of entire linx device was conducted on (b)(6) 2015.Patient condition reported as well following the explant procedure.
Additional Manufacturer Narrative
-addition of "p" to pma number, -addition of (b)(4) to evaluation codes.
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia leading to visualization of linx device beads within the esophageal lumen.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure and linx device implantation reported as (b)(6) 2014.-endoscopy completed (b)(6) 2015 due to dysphagia revealed a bead (titanium encased magnets) to be visible in the esophagus.The linx device was intact.-endoscopic removal of entire linx device was conducted on (b)(6) 2015.-patient condition reported as well following the explant procedure.

• 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: 5345277
• Report Number: 3008766073-2016-00002
• Device Sequence Number: 10935391
• Product Code: LEI
• UDI-Device Identifier: 00855106005134
• UDI-Public: 00855106005134
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Followup
• Report Date (Section B): 06/12/2017

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: 09/10/2018
• Device Model Number: LXC12
• Device Lot Number: 6726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2016
• Supplement Report FDA Received Date: 06/14/2017
• 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: 55 YR