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

Model Number LS14

Device Problem Insufficient Information (3190)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 06/24/2014

Event Type  Other  

Event Description

Following a laparoscopic anti-reflux procedure utilizing the linx device, a patient experienced dysphagia leading to linx device explant.Anti-reflux procedure and linx device implantation occurred on (b)(6) 2014.Dysphagia first reported as of (b)(6) 2013.Gastroesophageal balloon dilation occurred (b)(6) 2013 that temporarily alleviated symptoms.(b)(6) 2013, reported heartburn symptoms alleviated with some ongoing dysphagia.Patient satisfied with results.Uneventful device explant on (b)(6) 2014 due to ongoing symptoms (pain).Device found in the correct position and geometry.Anterior 180 degree fundoplication performed at time of linx explant.

• 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: 3982591
• MDR Text Key: 4820136
• Report Number: 3008766073-2014-00014
• 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: 06/24/2014

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: 06/04/2016
• Device Model Number: LS14
• Device Lot Number: 3626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2014
• Initial Date FDA Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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
• Treatment: HIATAL HERNIA REPAIR
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 60 YR
• Patient Weight: 78