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

Model Number UNKNOWN

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

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815); Regurgitation (2259)

Event Date 03/01/2017

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient was hospitalized for dysphagia, regurgitation, and pooling of saliva above the linx device.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure including hiatal hernia repair and linx device implantation occurred in (b)(6) 2017.-patient remained in the hospital because he "could not keep food or liquid down at all" and "pooling was an issue" as "saliva seemed to settle right above the band".He was discharged 3 days after the implant procedure.-patient returned to the hospital "for another 3-5 days".A dilation was performed.-patient admitted to the hospital a couple weeks later for the same issues.-the patient reports he was hospitalized for 13 days in the first 5 weeks following the linx implant.-a second dilation was performed to "18mm maybe" in (b)(6) 2017.After the dilation, the patient reported that "i seemed to be feeling better.Things were looking good and i was able to keep food and liquid down." -a barium swallow in (b)(6) 2017 resulted in "neither the liquid or pill going through." -patient reports that "in (b)(6) 2017, certain things i ate would get stuck.Nothing would help the situation.This was causing major pains in my chest." -a third dilation was performed in (b)(6) 2018.The patient believes it was to 20mm.The patient has experienced chest pains since the dilation.-a barium study was performed a week after the third dilation."during this test the liquid would pass through but the pill would not.The study seemed to also show some reflux as i was laying down." the patient was told that "there was some irritation in the esophagus.".

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; 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: 7325200
• MDR Text Key: 101956853
• Report Number: 3008766073-2018-00033
• Device Sequence Number: 1
• Product Code: LEI
• 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: Patient
• Type of Report: Initial
• Report Date: 02/08/2018

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: Physician
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 50 YR