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

Model Number	LXC13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	04/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced chest pain leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure including linx device implantation occurred without issue on (b)(6) 2014 by dr.(b)(6).-uneventful device explant due to pain on (b)(6) 2017 by dr.(b)(6) 2017.
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced chest pain leading to explant of the linx device.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure including linx device implantation occurred without issue on (b)(6) 2014 by dr.(b)(6).-patient prescribed medrol dose pack on (b)(6) 2016.-uneventful device explant due to pain on (b)(6) 2017 by dr.(b)(6).Surgeon noted that "it was scarred quite heavily and it was difficult to excise.He also noted that while he "retracted the linx device to the right and dissected around the beads the device broke" and that he then "pulled the other side to the left and dissected away on the other side and the device again broke." -patient "happy with no heartburn or pain" as of (b)(6) 2017.

• 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: 6564048
• Report Number: 3008766073-2017-00051
• Device Sequence Number: 749721
• Product Code: LEI
• UDI-Device Identifier: 00855106005141
• UDI-Public: 00855106005141
• Combination Product (Y/N): N
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 01/31/2018

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: 03/13/2017
• Device Model Number: LXC13
• Device Lot Number: 4516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 03/02/2018
• 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; Disability
• Patient Age: 69 YR
• Patient Weight: 77