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

Model Number	LS14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heartburn/Indigestion (1883)
Date of Event	05/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced ongoing gerd symptoms resulting in 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)2013; a small hiatal hernia was present but not repaired.-device explant due to ongoing gerd on (b)(6)2017; device was found within a hiatal hernia.-patient underwent a fundoplication immediately after device explant.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced ongoing gerd symptoms resulting in 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) 2013; a small hiatal hernia was present but not repaired.-device explant due to ongoing gerd on (b)(6) 2017; device was found within a hiatal hernia.-patient underwent a fundoplication immediately after device explant.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue n; shoreview MN 55126
• MDR Report Key: 6640570
• Report Number: 3008766073-2017-00057
• Device Sequence Number: 926565
• Product Code: LEI
• UDI-Device Identifier: 00855106005035
• UDI-Public: 00855106005035
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2017

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
• Operator of Device: Physician
• Device Expiration Date: 09/19/2016
• Device Model Number: LS14
• Device Lot Number: 3964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 49 YR
• Patient Weight: 71