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

Model Number	LXC14
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Pain (1994)
Date of Event	12/08/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced mild dysphagia and related pain leading to linx device explant.The linx device was used as part of the anti-reflux procedure.-uneventful anti-reflux procedure and device implant on (b)(6) 2015 by dr.(b)(6).- device explant (b)(6) 2016 due to mild dysphagia and related pain by dr.(b)(6).-device found in correct position/geometry at time of explant.
Additional Manufacturer Narrative
-addition to relevant tests/lab data and device available for evaluation? to include device evaluation.-addition to evaluation codes to include (b)(4).
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced mild dysphagia and related pain leading to linx device explant.The linx device was used as part of the anti-reflux procedure.-uneventful anti-reflux procedure and device implant on (b)(6) 2015 by dr.(b)(6) at (b)(6) hospital.-device explant (b)(6) 2016 due to mild dysphagia and related pain by dr.(b)(6) at (b)(6) medical center.-device found in correct position/geometry at time of 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: 6229056
• Report Number: 3008766073-2017-00006
• Device Sequence Number: 13621566
• Product Code: LEI
• UDI-Device Identifier: 00855106005158
• UDI-Public: 00855106005158
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2017

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: 11/17/2018
• Device Model Number: LXC14
• Device Lot Number: 7064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2017
• Supplement Report FDA Received Date: 02/07/2017
• 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; Disability
• Patient Age: 45 YR