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

Model Number LS14

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

Patient Problems Aspiration/Inhalation (1725); Regurgitation (2259)

Event Date 10/08/2015

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced regurgitation/aspiration leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implantation occurred without issue (b)(6) 2015.Uneventful device explant due to dysphagia on (b)(6) 2015.Device found in correct position/geometry.Patient in satisfactory condition after explant.

• 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: kevin klitz ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 5202120
• MDR Text Key: 30431402
• Report Number: 3008766073-2015-00046
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005035
• UDI-Public: 00855106005035
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2015

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: 05/29/2017
• Device Model Number: LS14
• Device Lot Number: 4781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2015
• Initial Date FDA Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2013
• 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: 54 YR
• Patient Weight: 98