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

Model Number	LXC13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	05/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure a patient experienced dysphagia and epigastric pain symptoms leading to endoscopic visualization of 2 linx device beads within the esophageal lumen and subsequent device removal.The linx device was used as part of the anti-reflux procedure.- anti-reflux procedure including linx device implantation occurred without issue on (b)(6) 2014 by dr.(b)(6) at (b)(6) memorial hospital.- patient had a new onset of dysphagia and epigastric pain in (b)(6) 2017.- endoscopy confirmed 2 linx device beads visible at the patient's posterior side of the esophagus.The linx device was intact.- 6 of 13 linx device beads were endoscopically removed without issue on (b)(6) 2017 by dr.(b)(6) at (b)(6) memorial hospital.Remaining beads are planned to be removed at a later date.
Event or Problem Description
Following a laparoscopic anti-reflux procedure a patient experienced dysphagia and epigastric pain symptoms leading to endoscopic visualization of 2 linx device beads within the esophageal lumen and subsequent partial device removal.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including linx device implantation occurred without issue on (b)(6) 2014 by dr.(b)(6) at (b)(6) hospital.Patient had a new onset of dysphagia and epigastric pain in (b)(6) 2017.Endoscopy confirmed 2 linx device beads visible at the patient's posterior side of the esophagus.The linx device was intact.The 6 of 13 linx device beads were endoscopically removed without issue on (b)(6) 2017 by dr.(b)(6) and dr.(b)(6) at (b)(6) hospital.The patient was reported as doing well after the partial device removal.An attempt to remove the remaining device beads (7) was made on (b)(6) 2017 by dr.(b)(6); the device was not able to be easily exposed (due to adhesions) and the case was abandoned.The patient was no longer experiencing the symptoms she had when the partial device was in the lumen.

• 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: 6657150
• Report Number: 3008766073-2017-00059
• Device Sequence Number: 13740636
• Product Code: LEI
• UDI-Device Identifier: 00855106005141
• UDI-Public: 00855106005141
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/24/2017

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: 05/07/2018
• Device Model Number: LXC13
• Device Lot Number: 6173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 08/23/2017
• 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: 81 YR