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

Model Number LXMC15

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

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 11/18/2016

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia leading to linx device explant.The linx device was used as part of the anti-reflux procedure.-uneventful anti-reflux procedure with hernia repair and device implant on (b)(6) 2016.-patient was admitted to er on (b)(6) 2016 with abdominal pain.Patient reported 13 lb.Weight loss one week after anti-reflux procedure and was unable to swallow saliva, food, or drink.-patient dilated on (b)(6) 2016 in an attempt to alleviate dysphagia symptoms.-device explant (b)(6) 2016 due to severe dysphagia.-device was found in the correct/position geometry at the time of removal.

• 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: daniel hoseck ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 6173807
• MDR Text Key: 62355568
• Report Number: 3008766073-2016-00105
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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: 11/18/2016

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: 08/13/2019
• Device Model Number: LXMC15
• Device Lot Number: 8775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• 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: 70 YR