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

Model Number LXMC16

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

Patient Problems Abdominal Pain (1685); Flatus (1865)

Event Date 11/04/2017

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient was hospitalized for gas/bloating and abdominal pain.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including hiatal hernia repair and linx device implantation occurred without issue on (b)(6) 2017.The patient "became extremely bloated" the evening of 11/03/2017.Patient admitted to emergency room on 11/04/2017 with bloating, abdominal pain, a "mottled" abdomen with "diffuse tenderness," and tachycardia.Patient diagnosed with colonic ileus, gastric distention with ischemia, acute kidney injury, and atrial fibrillation with rapid ventricular response (rvr).Patient received a nasogastric tube (ng) which required an esophagogastroduodenoscopy (egd) to get into place.Patient "responded quickly with ng decompression and proton-pump inhibitors (ppis), except had a prolonged colonic ileus with serial extended releases (xrs) showing a very distended colon." patient was still hospitalized on (b)(6) 2017, "mainly due to logistical reasons," as he was "doing way better," and was on a regular diet.Patient was discharged from the hospital on (b)(6) 2017 and is "doing well.".

• 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: 7065016
• MDR Text Key: 93163024
• Report Number: 3008766073-2017-00138
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/07/2017

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 Expiration Date: 08/04/2020
• Device Model Number: LXMC16
• Device Lot Number: 11831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Disability
• Patient Age: 66 YR