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 Pyrosis/Heartburn (1883); Complaint, Ill-Defined (2331)

Event Date 07/01/2016

Event Type  Injury  

Event Description

Following a laparoscopic anti-reflux procedure, a patient had the linx device explanted for unknown reasons; multiple requests for additional information have been made.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and device implant on (b)(6) 2007 by dr.(b)(6) at the (b)(6).Device explant in (b)(6) 2016 by dr.(b)(6) at the (b)(6).Patient underwent a fundoplication immediately after device explant.

Manufacturer Narrative

-update to describe event or problem to include date and reason for removal.-update to model #/lot # to include udi number.-update to explant date for date of explant.-update to evaluation codes to include (b)(4).

Event Description

Following a laparoscopic anti-reflux procedure, a patient experienced recurrent gerd symptoms leading to a linx device explant.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure and device implant on (b)(6) 2007 by dr.(b)(6) at (b)(6).-device explant on (b)(6) 2016 due to recurrent gerd by dr.(b)(6) at (b)(6).The patient requested the removal of the linx device.-patient underwent a fundoplication immediately after device explant.

• 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: jessica ahlborn ; 4188 lexington avenue north; shoreview, MN 55126 ; 6513618900
• MDR Report Key: 6210070
• MDR Text Key: 63409769
• Report Number: 3008766073-2016-00113
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2017

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: 10/29/2011
• Device Model Number: LS14
• Device Lot Number: 699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2007
• 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: 55 YR