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 Code	Dysphagia/ Odynophagia (1815)
Date of Event	08/24/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.A total of 9 of 12 linx beads were explanted on (b)(6) 2016.Three remaining beads were separated from device during explant.Physician does not plan to remove the remaining 3 beads.Patient reported as doing well after explant.
Additional Manufacturer Narrative
-patient identifying information: -bmi reported as (b)(6).-device traceability (lot and serial number) added and manufacturing paperwork reviewed.-patient continues to do well after device explant.
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia leading to explant of the linx device.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) 2014.-a total of 9 of 12 linx beads were explanted on (b)(6).Three remaining beads were separated from device during explant.-physician plans to remove the remaining 3 beads at a later date in combination with a fundoplication.-patient reported as doing well after explant.-additionally, patient is "happy, tolerating food, and doing well" as of 10/31/2016.

• 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: 5970843
• Report Number: 3008766073-2016-00066
• Device Sequence Number: 16240902
• Product Code: LEI
• UDI-Device Identifier: 00855106005134
• UDI-Public: 00855106005134
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2016

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: 05/09/2018
• Device Model Number: LXC12
• Device Lot Number: 6176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2016
• Supplement Report FDA Received Date: 12/13/2016
• 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: 51 YR