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

Model Number LXC15

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pyrosis/Heartburn (1883)

Event Date 08/13/2018

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced ongoing gerd symptoms 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 on (b)(6) 2014 without issue.-the patient reported ongoing gerd symptoms and the device was explanted without issue and a fundoplication was performed on (b)(6) 2018.-the linx device was in the correct position and geometry.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• Manufacturer (Section G): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN 55126
• Manufacturer Contact: steve nelson ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 7854778
• MDR Text Key: 119496871
• Report Number: 3008766073-2018-00145
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005165
• UDI-Public: 00855106005165
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/13/2018

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: No Information
• Device Expiration Date: 01/04/2017
• Device Model Number: LXC15
• Device Lot Number: 4279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2013
• 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; Other
• Patient Age: 66 YR