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

Model Number LX15

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

Patient Problem Regurgitation (2259)

Event Date 10/07/2014

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced fluid/regurgitation in the esophagus 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 without issue (b)(6) 2014.Gastroesophageal balloon dilation was attempted but did no alleviate symptoms.Uneventful device explant on (b)(6) 2014.Patient in satisfactory condition after explant.

• 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: 4249894
• MDR Text Key: 20778859
• Report Number: 3008766073-2014-00029
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: 100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2014

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: 12/17/2016
• Device Model Number: LX15
• Device Lot Number: 4239
• Other Device ID Number: 00855106005103
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2014
• Initial Date FDA Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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
• Patient Outcome(s): Hospitalization; Disability