MAUDE Adverse Event Report: TORAX MEDICAL, INC. LXC12; ANTI-REFLUX IMPLANT

Catalog Number	LXC12
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.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 was requested, and the following was obtained: what was the device size implanted (how many beads)? 12 (clasp).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)? no.Were there any intra-operative complications during implant? unknown.Was there any hiatal or crural repair done at the same time as the implant? no crural repair/stitches identified during explant.What was the reason for removal of the linx device? spasms.Was the device found in the correct position/geometry at the time of removal? yes.
Event or Problem Description
It was reported that the doctor implanted the linx device in the patient five years ago.The patient reported persistent dysphagia and the patient had an explant on (b)(6) 2018, where the entire device was removed from the patient.No observations or interventions were noted.It isn't known if the patient symptoms have persisted.

• Brand Name: LXC12
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 7947115
• Report Number: 3008766073-2018-00173
• Device Sequence Number: 2255004
• Product Code: LEI
• UDI-Device Identifier: 00855106005134
• UDI-Public: 00855106005134
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/15/2018

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: Health Professional
• Device Catalogue Number: LXC12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2018
• Initial Report FDA Received Date: 10/09/2018
• Patient Sequence Number: 1