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

Model Number LXMC14

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

Patient Problem Regurgitation (2259)

Event Date 10/19/2017

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced "significant regurgitation" which led to the removal of a linx device.The linx device was used as part of the anti-reflux procedure.-uneventful anti-reflux procedure including linx device implant occurred on (b)(6) 2017.-uneventful device explant occurred on (b)(6) 2017.-device was found in the correct position and geometry at time of removal.-post explant pain is being clinically managed with oxycodone and tylenol.

• 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: 7038862
• MDR Text Key: 92282502
• Report Number: 3008766073-2017-00131
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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: 10/19/2017

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: 04/25/2021
• Device Model Number: LXMC14
• Device Lot Number: 14624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2017
• 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; Other
• Patient Age: 60 YR
• Patient Weight: 88