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	Abdominal Pain (1685)
Date of Event	07/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient was hospitalized for severe chest pain.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 admitted to emergency room on (b)(6) 2017 with chest pain.The patient was given ppis.Patient was discharged from the hospital on (b)(6) 2017.Patient admitted to emergency room on (b)(6) 2017 with chest pain, and discharged within 24-hours.Patient hospitalized for less than 24 hours on (b)(6) 2018 with epigastric pain with nausea, dizziness, sweatiness, and shortness of breath.As of (b)(6) 2018, the patient is experiencing epigastric pain, gassiness and bloating, and is being managed by their physician.
Additional Manufacturer Narrative
Updated event to include device explant information.Updated relevant tests/laboratory data to include device analysis.Updated if explanted, give date to include explant date.Updated evaluation codes to include method codes 10, 84, and 3354.Updated report date.
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient was hospitalized for severe chest pain.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 admitted to emergency room on (b)(6) 2017 with chest pain.The patient was given ppis.Patient was discharged from the hospital on (b)(6) 2017.Patient admitted to emergency room on (9)(6) 2017 with chest pain, and discharged within 24-hours.Patient hospitalized for less than 24 hours on (b)(6) 2018 with epigastric pain with nausea, dizziness, sweatiness, and shortness of breath.As of (b)(6) 2018, the patient was experiencing epigastric pain, gassiness and bloating, and is being managed by their physician.Device explant due to severe chest pains occurred without issue on (b)(6) 2018 by dr.(b)(6).A hiatal hernia repair and partial (270 degree) fundoplication were performed at the time.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN 55126
• MDR Report Key: 7287212
• Report Number: 3008766073-2018-00025
• Device Sequence Number: 11024087
• Product Code: LEI
• UDI-Device Identifier: 00855106005141
• UDI-Public: 00855106005141
• 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: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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: 09/10/2017
• Device Model Number: LXC13
• Device Lot Number: 5189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 03/26/2018
• 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: 53 YR