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 Problem Hernia (2240)

Event Date 10/29/2014

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced recurrent reflux 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 (b)(6) 2013.Recurrent reflux reported as due to an intractable hernia.Patient had previously had hernia repair (b)(6) 2014.Uneventful device explant on (b)(6) 2014.Device found in correct position/geometry at time of explant.Patient in satisfactory condition.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL INC.; shoreview MN
• Manufacturer Contact: 4188 lexington ave n; shoreview, MN 55126-0000 ; 6513618900
• MDR Report Key: 4301340
• MDR Text Key: 5083775
• Report Number: 3008766073-2014-00036
• Device Sequence Number: 1
• Product Code: LEI
• 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: 10/29/2014

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: Health Professional
• Device Expiration Date: 04/09/2016
• Device Model Number: LS14
• Device Lot Number: 3456
• Other Device ID Number: 00855106005035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• 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
• Treatment: CRURAL REPAIR OCCURRED AT TIME OF ANTI-REFLUX; PROCEDURE.
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 35 YR