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 Codes	Abdominal Pain (1685); Erosion (1750); Heartburn/Indigestion (1883)
Date of Event	12/05/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia, pain and lpr symptoms 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.-patient experienced post-operative dysphagia treated via a savary dilator and subsequent chest pain.-endoscopy completed (b)(6) 2015 due to ongoing lpr symptoms revealed several beads (titanium encased magnets) to be visible in the esophagus.The linx device was intact.-endoscopic removal of entire device was conducted on (b)(6) 2015.-patient condition reported as well following the explant procedure.
Additional Manufacturer Narrative
Manufacturer narrative based on data obtained 02/09/2016: patient condition reported as 'well' after device explant.It was reported the patient underwent a 60 french dilation 8 weeks after the anti-reflux procedure.Device analysis conducted by torax medical engineering after product receipt.Gross analysis revealed no device anomalies atypical from an explanted device.Microscopic analysis revealed all device components and assembly exhibited normal characteristics of an explanted device.Force testing, length testing, and geometric analysis exhibited no anomalies.No conclusion relevant to experience determined.
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia, pain and lpr symptoms 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.Patient experienced post-operative dysphagia treated via a savary dilator and subsequent chest pain.Endoscopy completed (b)(6) 2015 due to ongoing lpr symptoms revealed several beads (titanium encased magnets) to be visible in the esophagus.The linx device was intact.Endoscopic removal of entire device was conducted on (b)(6) 2015.Patient condition reported as well following the explant procedure.
Additional Manufacturer Narrative
Manufacturer narrative based on data obtained 02/09/2016: patient condition reported as 'well' after device explant.It was reported the patient underwent a 60 french dilation 8 weeks after the anti-reflux procedure.Device analysis conducted by torax medical engineering after product receipt.Gross analysis revealed no device anomalies atypical from an explanted device.Microscopic analysis revealed all device components and assembly exhibited normal characteristics of an explanted device.Force testing, length testing, and geometric analysis exhibited no anomalies.No conclusion relevant to experience determined.Follow up report 2: (b)(4).
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia, pain and lpr symptoms 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.Patient experienced post-operative dysphagia treated via a savary dilator and subsequent chest pain.Endoscopy completed (b)(6) 2015 due to ongoing lpr symptoms revealed several beads (titanium encased magnets) to be visible in the esophagus.The linx device was intact.Endoscopic removal of entire 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: 5342113
• Report Number: 3008766073-2016-00001
• Device Sequence Number: 241751
• Product Code: LEI
• UDI-Device Identifier: 00855106005141
• UDI-Public: 00855106005141
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,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: 05/09/2018
• Device Model Number: LXC13
• Device Lot Number: 6174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/04/2016
• Supplement Report FDA Received Date: 03/07/2016; 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: 66 YR