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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/06/2017
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 explant.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure including linx device implantation and hernia repair on (b)(6) 2015.-uneventful device explant on (b)(6) 2017 due to need for a 3.0t mri.-device found in correct position/geometry at the time of removal.-fundoplication performed immediately after explant.
Event or Problem Description
Following a laparoscopic anti-reflux procedure, a patient required mri(s) for unrelated causes leading to linx device explant.The linx device was used as part of the anti-reflux procedure.-anti-reflux procedure including linx device implantation and hernia repair on (b)(6) 2015.-uneventful device explant on (b)(6) 2017 due to need for a 3.0t mri.-device found in correct position/geometry at the time of removal.-fundoplication performed immediately after 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: 6693784
• Report Number: 3008766073-2017-00074
• Device Sequence Number: 1604648
• Product Code: LEI
• UDI-Device Identifier: 00855106005158
• UDI-Public: 00855106005158
• 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,Followup
• Report Date (Section B): 07/07/2017

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: 08/12/2018
• Device Model Number: LXC14
• Device Lot Number: 6591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 07/13/2017
• 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: 54 YR