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 Unspecified Infection (1930)

Event Date 09/08/2016

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient had the linx device explanted due to infection at the implant site.The linx device was used as part of the anti-reflux procedure.Uneventful anti-reflux procedure, hernia repair, and device implant on (b)(6) 2016.Patient experienced nausea, dry heaving, vomiting and fever after device implant and received a chest x-ray on the night of (b)(6) 2016.Review of chest x-ray by implanting physician on the morning of (b)(6) 2016 showed that patient had a hernia in the area of the linx device.Laparoscopic surgery to repair hernia on (b)(6) 2016 revealed a significant amount of white-yellow fluid at implant site.Based on the presence of the white-yellow fluid the linx device was explanted.The implanting center reported that the explanted linx device could not be cultured due to contamination after removal from the patient.After device removal a fundoplication was performed.

Event Description

Following a laparoscopic anti-reflux procedure, a patient had the linx device explanted due to infection at the implant site.The linx device was used as part of the anti-reflux procedure.Uneventful anti-reflux procedure, hernia repair, and device implant on (b)(6) 2016.Patient experienced nausea, dry heaving, vomiting and fever after device implant and received a chest x-ray on the night of (b)(6) 2016.Review of chest x-ray by implanting physician on the morning of (b)(6) 2016 showed that patient had a hernia in the area of the linx device.Laparoscopic surgery to repair hernia on (b)(6) 2016 revealed a significant amount of white-yellow fluid at implant site.Based on the presence of the white-yellow fluid the linx device was explanted.The implanting center reported that the explanted linx device could not be cultured due to contamination after removal from the patient.After device removal a fundoplication was performed.

• 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: 6012516
• MDR Text Key: 56913683
• Report Number: 3008766073-2016-00068
• 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: 10/18/2016

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: 04/05/2020
• Device Model Number: LXMC17
• Device Lot Number: 10717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2016
• Initial Date FDA Received: 10/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• 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; Other
• Patient Age: 62 YR