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 Code	Erosion (1750)
Date of Event	08/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient had an endoscopic visualization of 2 device beads eroded into the esophageal lumen and subsequent explant of a portion of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including linx device implant on (b)(6) 2013 at (b)(6) hospital.Two (2) device beads were observed endoscopically on the posterior side of the esophageal lumen on (b)(6) 2017.The device was found intact.Seven (7) of thirteen (13) linx device beads were explanted endoscopically on (b)(6) 2017 at (b)(6) school of medicine.The patient was doing well after removal.
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient had an endoscopic visualization of 2 device beads eroded into the esophageal lumen and subsequent explant of a portion of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including linx device implant on (b)(6) 2013 at (b)(6) hospital.The patient caught a boom across her abdomen in a sailboat accident 9 days prior to experiencing sharp, epigastric abdominal pain with associated belching.The 2 device beads were observed endoscopically on the posterior side of the esophageal lumen on (b)(6) 2017.The device was found intact.7 of 13 linx device beads were explanted endoscopically on (b)(6) 2017 at (b)(6) school of medicine.The patient was doing well after removal and dysphagia resolved.
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient had an endoscopic visualization of 2 device beads eroded into the esophageal lumen and subsequent explant of a portion of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including linx device implant on (b)(6) 2013 at (b)(6) hospital.The patient caught a boom across her abdomen in a sailboat accident 9 days prior to experiencing sharp, epigastric abdominal pain with associated belching.2 device beads were observed endoscopically on the posterior side of the esophageal lumen on (b)(6) 2017.The device was found intact.The 7 of 13 linx device beads were explanted endoscopically on (b)(6) 2017 at (b)(6) school of medicine.The patient was doing well after removal and dysphagia resolved.The remaining 6 linx device beads were explanted laparoscopically without issue on (b)(6) 2017.The patient was doing well after removal.

• 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: 6826534
• Report Number: 3008766073-2017-00099
• Device Sequence Number: 18848383
• Product Code: LEI
• UDI-Device Identifier: 00855106005028
• UDI-Public: 00855106005028
• 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: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2017

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: 06/03/2017
• Device Model Number: LS13
• Device Lot Number: 4793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 08/30/2017; 10/24/2017
• Initial Report FDA Received Date: 08/29/2017
• Supplement Report FDA Received Date: 09/27/2017; 11/22/2017
• 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: 69 YR