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

Model Number LXMC14

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

Patient Problems Pyrosis/Heartburn (1883); Regurgitation (2259)

Event Date 08/15/2018

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced ongoing gerd and regurgitation leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure including linx device implantation and hernia repair occurred without issue in (b)(6) of 2016 ((b)(6) 2016).-patient had an esophagogastroduodenoscopy (egd) with dilation post linx implantation.-device explant due to ongoing gerd and regurgitation occurred without issue on (b)(6) 2018.-the device was found in the correct position/geometry at the time of removal.-a conversion to a roux-en-y gastric bypass was performed after device removal without issue.

Manufacturer Narrative

Updated relevant tests/laboratory data to include device analysis.Updated concomitant medical products to include date returned to manufacturer updated to include patient code 2259 and method code 10.Updated report date.

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced ongoing gerd and regurgitation leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including linx device implantation and hernia repair occurred without issue in april of 2016 on (b)(6) 2016).Patient had an esophagogastroduodenoscopy (egd) with dilation post linx implantation.Device explant due to ongoing gerd and regurgitation occurred without issue on (b)(6)2018.The device was found in the correct position/geometry at the time of removal.A conversion to a roux-en-y gastric bypass was performed after device removal without issue.

• 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
• MDR Report Key: 7876198
• MDR Text Key: 120241146
• Report Number: 3008766073-2018-00147
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

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: 12/10/2019
• Device Model Number: LXMC14
• Device Lot Number: 9763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 10/16/2018
• Supplement Dates FDA Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 36 YR