MAUDE Adverse Event Report: TORAX MEDICAL, INC. LS13; ANTI-REFLUX IMPLANT

Catalog Number	LS13
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); No Code Available (3191)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The lot was not provided; therefore, the manufacturing records could not be reviewed.Additional information was requested, and the following was received: on wat date did the implant take place (please provide full date)? na.What is the product code for the linx device that was removed (lxms13 is not a valid product code)? it¿s the 13 bead pre clasp- it used suture to close device.What is the lot number of the linx device? na.Did the patient have an autoimmune disease? no.Is the patient currently taking steroids / immunization drugs? no.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? dysphagia.How severe was the dysphagia/odynophagia before intervention?severe enough to have it removed.Were there any intra-operative complications during implant? no.Was there any hiatal or crural repair done at the same time as the implant? na.Were there any other contributing factors that led to the removal of the device other than the reported dysphagia? no.Was the device found in the correct position/geometry at the time of removal? yes.
Event or Problem Description
It was reported that the patient originally had the linx implanted in 2014.Patient was complaining about dysphagia as the reason for device removal.Prior to the explant, dilations and steroids were tried but did not work.The physician did not have any notable observations.The device was removed without incident.

• Brand Name: LS13
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8918253
• Report Number: 3008766073-2019-00422
• Device Sequence Number: 16601415
• Product Code: LEI
• UDI-Device Identifier: 00855106005028
• UDI-Public: 00855106005028
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: LS13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/21/2019
• Patient Sequence Number: 1