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

Model Number LXMC17

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

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 11/19/2016

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Uneventful device implant and hiatal hernia repair on (b)(6) 2016.Patient was converted from nissen fundoplication to linx.Patient experienced frequent regurgitation and aspiration.Patient had acute exacerbation of his autonomic issues resulting in a decline in his oropharyngeal swallowing mechanism requiring swallowing retraining.The retraining was going to take weeks and the patient would only be allowed oral intake of honey-thick liquids.Based on this the physician felt that the device should be removed.Uneventful device explant on (b)(6) 2016.The device was found in the correct position/geometry at the time of removal.

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced dysphagia leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Uneventful device implant and hiatal hernia repair on (b)(6) 2016.Patient was converted from nissen fundoplication to linx.Patient experienced frequent regurgitation and aspiration.Patient had acute exacerbation of his autonomic issues resulting in a decline in his oropharyngeal swallowing mechanism requiring swallowing retraining.The retraining was going to take weeks and the patient would only be allowed oral intake of honey-thick liquids.Based on this, the physician felt that the device should be removed.Uneventful device explant on (b)(6) 2016.The 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: jessica ahlborn ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 6187735
• MDR Text Key: 62785082
• Report Number: 3008766073-2016-00107
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• 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,Followup
• Report Date: 01/25/2017

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: 08/24/2020
• Device Model Number: LXMC17
• Device Lot Number: 12003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2016
• 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: 63 YR