MAUDE Adverse Event Report: TORAX MEDICAL, INC. LXC13; ANTI-REFLUX IMPLANT

Model Number LXC-[13]

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Muscle Spasm(s) (1966); Nausea (1970); Vomiting (2144)

Event Date 01/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 03/17/2020.Additional information received: have been prescribed nausea, spasm & heart burn medicines.Had egd w/bravo ph testing performed since 2016 & just had an egd on (b)(6) 2020.Chest pain, fullness in throat area which enables food and liquids to go down, rejuration attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Have the symptoms improved with the taking of the prescribed medications? what are the next steps recommended for this patient?.

Event Description

It was reported that linx implant device.Reports having pain, difficulty swallowing with water.A lot of tightness in the chest area, nausea and spasms.It is unknown what the next steps are with regards to treatment.

Manufacturer Narrative

(b)(4).The dhr for serial number (b)(6) within lot number 5028 was reviewed.No ncs, defects, or reworks related to the product complaint were found.Additional information received: had an egd on 2/20 which included widening of my esophagus.Still experiencing difficulty w/swallowing, regurgitation& tightness in chest area.Take ondansetron for nausea, tizanidine & chlordiazepoxide clidinium for spasms & pantoprazole sodium for reflux.Medications help somewhat.

Manufacturer Narrative

(b)(4).Date sent: 4/13/2021.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Additional information was obtained: a trx_2012_01 subject has experienced an ae.Subject id: (b)(6).Ae #: 1.Onset date: (b)(6) 2020.Date of ae awareness: 18-nov-2020.Event description: pt.C/o chest pain & regurgitation.Event characterization (from listing): dysphagia blank.Ae status/outcome: resolved.Date resolved: (b)(6) 2020.Severity: moderate.Is the event serious?: no.Relationship to the device/procedure: no/unlikely.Risks of linx device implantation procedure and/or device: dysphagia.Healthcare utilization: medication: checked please specify: pantoprozole.Office/clinical visit: checked date: (b)(6) 2020.Dilation ¿ pneumatic: checked date: (b)(6) 2020.Explant: checked date: (b)(6) 2020.Comments: date of esophagram not documented.Implant date: (b)(6) 2015.Device size: 13.Linx device model: clasp.Lot number: 5028.Serial number: (b)(6).To date no device has been returned for analysis.

• Brand Name: LXC13
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 9843653
• MDR Text Key: 186546310
• Report Number: 3008766073-2020-00047
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005141
• UDI-Public: 00855106005141
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2017
• Device Model Number: LXC-[13]
• Device Catalogue Number: LXC13
• Device Lot Number: 5028
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 03/23/2020; 03/18/2021
• Supplement Dates FDA Received: 04/13/2020; 04/13/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention