MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 17 BEADS; ANTI-REFLUX IMPLANT

Catalog Number	LXMC17
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 10/3/2024.Corrected data: d1, d4.Additional information received: the customer sent back a lxmc17.The customer said it should have been reported as a lxmc17.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/25/2024.Additional information was requested, and the following was obtained: prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? when using the linx sizing device what technique was used to determine the size? did the patient have an autoimmune disease? is the patient currently taking steroids / immunosuppressive drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? how severe was the dysphagia/odynophagia before intervention? were there any intra-operative complications during implant? was there any hiatal or crural repair done at the same time as the implant? were there any other contributing factors that led to the removal of the device other than the reported dysphagia? besides the reported dysphagia, what was the reason for removal of the linx device? was the device found in the correct position/geometry at the time of removal? answer: no further information from the customer at this time.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/10/2024.B3: only event year known: 2024.D6a: exact date is unknown.Assumed first day of the month and first month of the year.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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 the linx was explanted due to dysphagia.The patient's implant was done in 2019 and had no issues for 5 years.Linx was explanted on (b)(6) 2024.Patient is recovering well with no further issues.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/6/2024.Corrected data: d4 lot number, d4 expiration date, h4 manufacture date.H11: the manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.A lot number was not provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/8/2024.Additional information was requested, and the following was obtained: it was reported that the lot number for this event was 24768.However, the lot number of 24768 is for a lxmc14.When the device was returned a lxmc17 was received and upon asking for additional information it was stated that a lxmc17 was the product code for this event.Was the lot number of 24768 reported incorrectly? what was the lot number for this event? requested added info from the customer.No additional information is available at this time.Thxs.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/12/2024 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.Visual analysis was consistent with an explanted device, significant tooling marks were noted in some beads.Link length and tensile force were found to meet the applicable specifications.Overall, no analysis conclusions relevant to the patient experience were found.

• Brand Name: 1.5T LINX, 17 BEADS
• 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: 19499859
• Report Number: 3008766073-2024-00092
• Device Sequence Number: 7907557
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• 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: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/12/2024

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: 03/18/2023
• Device Catalogue Number: LXMC17
• Device Lot Number: 24768
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: 06/12/2024; 09/25/2024; 10/28/2024; 10/28/2024; 11/08/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 06/25/2024; 10/03/2024; 11/06/2024; 11/08/2024; 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown