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

Model Number	LS13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heartburn/Indigestion (1883)
Date of Event	09/07/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced ongoing gerd with associated gas and nausea leading to linx device explant.The linx device was used as part of the anti-reflux procedure.Patient experienced dysphagia before device implant that required dilations on at least 2 occasions; uneventful anti-reflux procedure and device implant on (b)(6) 2012; uneventful device explant (b)(6) 2016; immediately after device explant the patient had a replacement linx device implanted; patient is reportedly "doing great!" after implantation of a replacement linx device.Patient reports that nausea, acid reflux and heartburn have been resolved.
Additional Manufacturer Narrative
Device analysis conducted by torax medical engineering after product receipt.Gross analysis revealed no device anomalies atypical from an explanted device.Microscopic analysis revealed all device components and assembly exhibited normal characteristics of an explanted device.Force testing, length testing, and geometric analysis exhibited no anomalies.No conclusion relevant to experience determined.
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient experienced ongoing gerd with associated gas and nausea leading to linx device explant.The linx device was used as part of the anti-reflux procedure.Patient experienced dysphagia before device implant that required dilations on at least 2 occasions.Uneventful anti-reflux procedure and device implant on (b)(6) 2012.Uneventful device explant (b)(6) 2016.Immediately after device explant the patient had a replacement linx device implanted.Patient is reportedly "doing great!" after implantation of a replacement linx device.Patient reports that nausea, acid reflux and heartburn have been resolved.

• 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: 6030170
• Report Number: 3008766073-2016-00071
• Device Sequence Number: 19060337
• Product Code: LEI
• UDI-Device Identifier: 00855106005028
• UDI-Public: 00855106005028
• 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
• Report Date (Section B): 10/25/2016

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: 03/31/2016
• Device Model Number: LS13
• Device Lot Number: 3441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2016
• Supplement Report FDA Received Date: 11/21/2016
• 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: 62 YR