MAUDE Adverse Event Report: TORAX MEDICAL INC. LINX REFLUX MANAGEMENT SYSTEM

Model Number LXC13

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

Patient Problems Pyrosis/Heartburn (1883); Burning Sensation (2146)

Event Date 04/15/2014

Event Type  Other  

Event Description

Following a laparoscopic anti-reflux procedure utilizing the linx device, a pt experienced ongoing gerd symptoms leading to linx device implant.Anti-reflux procedure and linx device implantation occurred on (b)(6) 2013.Pt reported limited gerd relief including persistent burning in throat with linx device implanted.Uneventful device explant on (b)(6) 2014.Device found in the correct position and geometry.Pt is satisfied symptoms resolved.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Manufacturer (Section D): TORAX MEDICAL INC.; shoreview MN
• Manufacturer Contact: 4188 lexington ave n; shoreview, MN 55126 ; 6513618907
• MDR Report Key: 4071182
• MDR Text Key: 18790885
• Report Number: 3008766073-2014-00022
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 100049
• 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: 08/11/2014

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
• Device Expiration Date: 03/13/2017
• Device Model Number: LXC13
• Device Lot Number: 4516
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2014
• Initial Date FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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
• Patient Age: 25 YR
• Patient Weight: 65