MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 14B; ANTI-REFLUX IMPLANT

Catalog Number	LXMC14
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Heartburn/Indigestion (1883); Hernia (2240)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent 4/5/2024 d4 batch # unk b3: unknown; captured as awareness date d6a: exact date unk.Implanted in 2018.Assumed first day of the month and the first month of the year.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that patient had a size 14 linx implanted for treatment of gerd in 2018 at an unknown facility in north carolina.Patient began recently treating with another physician for return of symptoms and device was found to be discontinuous.Patient is in the process of scheduling removal of the linx device and counsel for patient will allow device analysis and provide necessary information.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/1/2024.A manufacturing record evaluation was performed for the finished device 17614 number, and no non-conformances related to the malfunction were identified.
Additional Manufacturer Narrative
(b)(6) date sent: (b)(6)2024 additional information received: spoke with patient who indicated her explant procedure is scheduled for 5/21.She is agreeable to releasing device for analysis and is no longer represented by counsel.Spoke with daniel in surgeon¿s office who was in clinic and will respond when free.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/11/2024.Investigation summary.Overall review of the device function and dimensions show no anomalies from a device that has been reasonably changed as part of the explant procedure, the device was received with one bead disconnected and during the analysis, it was noted that wires were cut.Visual analysis was consistent with an explanted device, and link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.A manufacturing record evaluation was performed for the finished device 17614 number, and no non-conformances related to the malfunction were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/13/2025, corrected data: d6a.See attached op notes.

• Brand Name: 1.5T LINX, 14B
• Common Device Name: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4545 creek road; cincinnati OH
• Manufacturer Contact: kate karberg ; 4545 creek rd.; cincinnati, OH 45242 ; 3035526892
• MDR Report Key: 19049458
• Report Number: 3008766073-2024-00054
• Device Sequence Number: 7355293
• Product Code: LEI
• UDI-Device Identifier: 00855106005349
• UDI-Public: 00855106005349
• 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 Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/13/2025

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 Expiration Date: 11/29/2021
• Device Catalogue Number: LXMC14
• Device Lot Number: 17614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 04/26/2024; 05/03/2024; 06/06/2024; 01/10/2025
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 05/01/2024; 05/07/2024; 06/11/2024; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female