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

Model Number	LXC-[15]
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Heartburn/Indigestion (1883); Vomiting (2144)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via clinical trial patient trx_2012_01: subject id: (b)(6) experience, increased reflux symptoms including heartburn and regurgitation since last annual visit.Started (b)(6) 2021, ongoing at time of report.The subject had linx implanted on (b)(6)2014.Medication: checked please specify: ppi prn.Relationship to the device/procedure: yes/probably/possibly.
Additional Manufacturer Narrative
(b)(4).Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information provided: a trx_2012_01 subject has experienced an ae.Subject id: (b)(6).Onset date: (b)(6) 2021.Date of ae awareness: (b)(6) 2022.Event description: subject has experienced increased reflux symptoms including heartburn and regurgitation since last annual visit.Event characterization (from listing): regurgitation blank ae status/outcome: ongoing at time of report severity: moderate relationship to the device/procedure: yes/probably/possibly.Risks of linx device implantation procedure and/or device: regurgitation.Medication: checked please specify: ppi prn.Implant date: (b)(6) 2014.Device size: 15.Linx device model: clasp.Lot number: 4882.Serial number: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/21/2022 investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device batch number 4882, and no non-conformances were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.

• Brand Name: LXC15
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 13807732
• Report Number: 3008766073-2022-00057
• Device Sequence Number: 4701409
• 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: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2022

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: 06/20/2017
• Device Model Number: LXC-[15]
• Device Catalogue Number: LXC15
• Device Lot Number: 4882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown