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

Model Number LXMC16

Device Problem Defective Component (2292)

Patient Problems Abdominal Pain (1685); Pyrosis/Heartburn (1883)

Event Date 05/03/2018

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced pain, coughing, and ongoing gerd symptoms that led to x-ray visualization of the linx device open.This led to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including hernia repair and linx device implantation occurred on (b)(6) 2016.X-ray in (b)(6) 2017 appeared to show a continuous linx device.Patient had a "right inguinal hernia repair with mesh on (b)(6) 2017 performed by an outside physician.Esophagram on (b)(6) 2018 visualized the discontinuous device.X-ray showed that the device was intact; however, bead-to-bead separation was larger than normal.Device explant due to the device opening occurred without issue on (b)(6) 2018.A nissen fundoplication was performed at the time of removal.

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced pain, coughing, and ongoing gerd symptoms that led to x-ray visualization of the linx device open.This led to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including hernia repair and linx device implantation occurred on (b)(6) 2016.X-ray in (b)(6) 2017 appeared to show a continuous linx device.Patient had a "right inguinal hernia repair with mesh on (b)(6) 2017 performed by an outside physician.Esophagram on (b)(6) 2018 visualized the discontinuous device.X-ray showed that the device was intact; however, bead-to-bead separation was larger than normal.Device explant due to the device opening occurred without issue on (b)(6) 2018.A nissen fundoplication was performed at the time of removal.

Manufacturer Narrative

(b)(4).Date sent: 10/30/2023.The fda received the initial and the follow up report #2.This report is submitted per the request of the fda as follow up report #1 had not been received.All details of this event was captured in the initial report under manufacture report number 3008766073-2018-00094.

• 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: tressa lauer ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 7562486
• MDR Text Key: 109836530
• Report Number: 3008766073-2018-00094
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005363
• UDI-Public: 00855106005363
• 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: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/04/2020
• Device Model Number: LXMC16
• Device Lot Number: 11831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 06/29/2018
• Supplement Dates FDA Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2016
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 70 KG