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

Model Number	LXC-[15]
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Heartburn/Indigestion (1883); Pain (1994); No Code Available (3191)
Date of Event	05/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The dhr for lot 7056 was reviewed.No ncs, reworks, or defects related to the product complaint were found.I do have a hiatal and asthma.I am also receiving allergy shots.I see a cardiologist due to frequents chest pain believed to be caused by the acid reflux.Testing done: 48-hour bravo test, ph.The doctor thinks the linx device is too tight and that there are adhesions around it.The device will not be explanted at this time.He will perform another endoscopy and try to open it with a balloon and treat the adhesion scars with medication to reduced inflammation.Since we last communicated my symptoms became worse, i couldn't swallow to the point i chocked a few times and i was scare to eat.On (b)(6) 2020 i finally had surgery.A endoscopic balloon dilatation (ebd).I just had a follow up today (b)(6) 2020 with the doctor.He explained that the beads n the linx device were stock together and i also had scar tissues around it.He prescribed steroids after surgery and recommends eating every two hours to keep the linx from closing.There are other procedures that can be done but for now.I am going to follow his indications and hope that everything works.At this time i am able to eat without the food getting stuck in my esophagus.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.
Event or Problem Description
It was reported that an unknown linx device was implanted on (b)(6) 2015, due to acid reflux.Since that time, the patient has started to have a recurrence of acid reflux, problems swallowing and chest pains.The patient consulted with her cardiologist and was referred to a gi clinic for tests.The device is still implanted.

• Brand Name: LXC15
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10191953
• Report Number: 3008766073-2020-00086
• Device Sequence Number: 16952405
• Product Code: LEI
• UDI-Device Identifier: 00855106005165
• UDI-Public: 00855106005165
• Combination Product (Y/N): N
• PMA/510(K) Number: P100049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2018
• Device Model Number: LXC-[15]
• Device Catalogue Number: LXC15
• Device Lot Number: 7065
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 06/24/2020
• Patient Sequence Number: 1