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

Model Number	LXC15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Heartburn/Indigestion (1883)
Date of Event	09/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient required mri(s) for unrelated causes leading to linx device demagnetization and explant.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure including hernia repair and 0.7t mri compatible linx device implantation occurred without issue on (b)(6) 2015.Patient underwent 1.5t mri of his hip implants on (b)(6) 2016.Reported "progressively worsening reflux" and some dysphagia on (b)(6) 2017.X-ray fluoroscopy of the esophagus on (b)(6) 2017 showed "splaying of metallic beads of patient's linx device without contrast bolus" and gastroesophageal reflux.Uneventful device explant on (b)(6) 2017 following demagnetization by an mri machine and onset of reflux and dysphagia symptoms.Device found in correct position at the time of removal.A second linx device (model: lxmc16, lot # 14184) was implanted at the time of surgery.

• 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: 7014590
• Report Number: 3008766073-2017-00128
• Device Sequence Number: 102093
• Product Code: LEI
• UDI-Device Identifier: 00855106005165
• UDI-Public: 00855106005165
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2017

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: 07/30/2018
• Device Model Number: LXC15
• Device Lot Number: 6542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 11/09/2017
• 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: 66 YR