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

Model Number	LS12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	07/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure a patient experienced reflux, dysphagia and odynophagia symptoms leading to endoscopic visualization of two linx device beads within the esophageal lumen in (b)(6) 2016.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure and linx device implantation occurred without issue on (b)(6) 2012.-esophagogastroduodenoscopy (egd) performed in (b)(6) 2016 due to reflux, dysphagia, and odynophagia showed two linx device beads in the esophageal lumen.-uneventful endoscopic explant of 3 linx device beads on (b)(6) 2016 after patient secured health insurance.The physician plans to laparoscopically remove the remainder of the device in 3-4 months.-patient in satisfactory condition after explant.
Additional Manufacturer Narrative
Updated narrative includes: -the physician laparoscopically removed the remaining 9 beads on (b)(6) 2016 and reported that "all went well," during the explant.-on (b)(6) 2016 the patient was reported as doing well with "no problems" after device explant.Updated narrative includes: -24 hours after removal of the remaining 9 linx device beads the patient underwent a barium swallow in which the patient's ugi "looked fine;" the patient was then discharged.
Event or Problem Description
Following a laparoscopic anti-reflux procedure a patient experienced reflux, dysphagia and odynophagia symptoms leading to endoscopic visualization of two linx device beads within the esophageal lumen in (b)(6) 2016.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure and linx device implantation occurred without issue on (b)(6) 2012.-esophagogastroduodenoscopy (egd) performed in (b)(6) 2016 due to reflux, dysphagia, and odynophagia showed two linx device beads in the esophageal lumen.-uneventful endoscopic explant of 3 linx device beads on (b)(6) 2016 after patient secured health insurance.-the physician removed the remaining 9 beads on (b)(6) 2016 and reported that "all went well," during the explant.-on (b)(6) 2016 the patient was reported as doing well with "no problems" after device explant.
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced reflux, dysphagia and odynophagia symptoms leading to endoscopic visualization of two linx device beads within the esophageal lumen in (b)(6) 2016.The linx device was used as part of the anti-reflux procedure.Anti-reflux procedure and linx device implantation occurred without issue on (b)(6) 2012.The patient began experiencing painful swallowing and trouble swallowing in (b)(6) 2016.It was reported that the patient's food needed to be pureed, and that they lost weight.Esophagogastroduodenoscopy (egd) performed in (b)(6) 2016 due to reflux, dysphagia, and odynophagia showed two linx device beads in the esophageal lumen.Uneventful endoscopic explant of 3 linx device beads on (b)(6) 2016 after patient secured health insurance.The physician removed the remaining 9 beads on (b)(6) 2016 and reported that "all went well," during the explant.On (b)(6)2016 the patient was reported as doing well with "no problems" after device explant.On (b)(6)2018, it was reported that the patient continued to have dysphagia and odynophagia after device removal and has been unable to work.
Additional Manufacturer Narrative
Updated event to include start of symptoms and continued patient status.Updated report date.

• 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: 6073434
• Report Number: 3008766073-2016-00078
• Device Sequence Number: 10978627
• Product Code: LEI
• UDI-Device Identifier: 00855106005011
• UDI-Public: 00855106005011
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2018

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: 04/10/2016
• Device Model Number: LS12
• Device Lot Number: 3457
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2016
• Supplement Date Received by Manufacturer: Not provided; 10/29/2018
• Initial Report FDA Received Date: 11/02/2016
• Supplement Report FDA Received Date: 12/21/2016; 11/20/2018
• 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: 34 YR