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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Type  Injury  

Event 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 at (b)(6) without issue in (b)(6) 2013.Uneventful device explant at the mayo jacksonville by dr.Steven bowers.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL INC.; shoreview MN
• Manufacturer Contact: 4188 lexington ave n; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 4273146
• MDR Text Key: 5297391
• Report Number: 3008766073-2014-00034
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2014

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2014
• Initial Date FDA Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability