MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Catalog Number	LXMC15
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	11/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) date sent 12/9/2024 d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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.No lot number was provided therefore a device history could not be done.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: what is the lot number of the linx device? 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? was the device found in the correct position/geometry at the time of removal? what was the date of the imaging which showed the discontinuous linx? if available, please share a copy of this imaging.Please send to: productcompliant1@its.Jnj.Com.Was the device initially effective in controlling reflux? were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient undergo an mri since device implant? if so, when was the mri and what strength? did the patient have any other surgeries in the area? did the patient receive any dilations while the linx was implanted? was any additional imaging performed since device implant? does the device appear to be in a continuous annular state in these images? we are interested in establishing a window when the device may have become discontinuous.Please share any additional images.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? will the device be returning for analysis? prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? 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 a linx was discontinuous.The clasp was still intact.Discontinuous device was found during x-ray.Patient was experiencing dysphagia.Patient was doing well at the time of discharge.Another device was not implanted.Surgeon did a partial fundoplication.

• Brand Name: 1.5T LINX, 15B
• 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: 20877604
• Report Number: 3008766073-2024-00168
• Device Sequence Number: 7804801
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2024

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 Catalogue Number: LXMC15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown