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

Model Number LXMC17

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

Patient Problem Perforation of Esophagus (2399)

Event Date 06/24/2015

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a pt experienced dry-heaving and a distended belly.Upon further diagnosis was determined an esophageal perforation existed.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implantation occurred on (b)(6) 2015 with no noted complications.Pt experienced dry-heaving for multiple days and distended belly leading to diagnosis of esophageal perforation.Perforation was described as a small posterior esophageal hole.Device explanted on (b)(6) 2015 by dr.(b)(6) of the (b)(6) with no notable observations about linx device.Linx device found in correct position/geometry.It was not determined the cause of the perforation (e.G., surgical damage, damage due to dry-heaving, etc.).Pt is 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: 4939618
• MDR Text Key: 19434507
• Report Number: 3008766073-2015-00029
• 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: 06/24/2015

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: 05/13/2019
• Device Model Number: LXMC17
• Device Lot Number: 8179
• Other Device ID Number: 00855106005370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2015
• Initial Date FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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; Other
• Patient Age: 73 YR