MAUDE Adverse Event Report: TORAX MEDICAL, INC. LXC15; ANTI-REFLUX IMPLANT

Model Number	LXC-[15]
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 03/05/2020.Only event year known: 2019.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information provided: implant date: (b)(6) 2013.No intra-operative complications during implant.No hiatal or crural repair done at the time of implant.Linx was surgically removed on (b)(6) 2020.
Event or Problem Description
It was reported, "in (b)(6) 2013, my gi surgeon tested the symptoms for gerd and determined i was perfect candidate for the linx device.After wearing the device for six years now, recently i've developed pain, irritation, and breathing pressure at the device location on the esophagus.In recent months, my medical providers have performed a ct scan, colonoscopy, endoscopy, esophagram, and fluoroscopic evaluation of esophageal motility.All of these test results found no evidence of other medical issues.Therefore, i'm certain the linx is causing my extremely low quality of life.My gi surgeon is no longer at the hospital.Requesting how to get the linx device removed.
Additional Manufacturer Narrative
(b)(4).Date sent: 04/08/2020.Device analysis: overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.The dhr for serial number (b)(6) from the lot number 4853 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

• Brand Name: LXC15
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9792994
• Report Number: 3008766073-2020-00038
• Device Sequence Number: 11621054
• Product Code: LEI
• UDI-Device Identifier: 00855106005165
• UDI-Public: 00855106005165
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: Health Professional
• Device Expiration Date: 06/11/2017
• Device Model Number: LXC-[15]
• Device Catalogue Number: LXC15
• Device Lot Number: 4853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 04/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention