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); Chest Pain (1776)
Date of Event	01/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced chest pain leading to endoscopic visualization of 1-2 device beads eroded into the esophageal lumen and subsequent endoscopic explant of the eroded linx device beads.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implantation occurred without issue (b)(6) 2014.Patient presented with chest pain (b)(6) 2017.The 1-2 device beads were observed endoscopically on (b)(6) 2017 in the posterior side of the esophageal lumen.Three beads of the linx device were removed endoscopically with a loop-cutter on (b)(6) 2017; patient was reported as doing well after the procedure.
Additional Manufacturer Narrative
Attempted removal of remaining linx device beads on (b)(6) 2017.
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced chest pain leading to endoscopic visualization of 1-2 device beads eroded into the esophageal lumen and subsequent endoscopic explant of the eroded linx device beads.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implantation occurred without issue (b)(6) 2014.Patient presented with chest pain (b)(6) 2017.One to two device beads were observed endoscopically on (b)(6) 2017 in the posterior side of the esophageal lumen.Three beads of the linx device were removed endoscopically with a loop-cutter on (b)(6) 2017; patient was reported as doing well after the procedure.A laparoscopic procedure to remove the remaining nine beads occurred on (b)(6) 2017; no beads were present as confirmed by a chest x-ray."the only thought is it migrated into the lumen and she passed it." the patient had a partial fundoplication on (b)(6) 2017 and was reported as doing well.

• 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: 6307487
• Report Number: 3008766073-2017-00017
• Device Sequence Number: 1031687
• Product Code: LEI
• UDI-Device Identifier: 00855106005134
• UDI-Public: 00855106005134
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2017

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: 05/09/2018
• Device Model Number: LXC12
• Device Lot Number: 6176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 05/15/2017
• 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: 58 YR
• Patient Weight: 49