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); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Inflammation (1932); Swelling/ Edema (4577)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 5/21/2024.B3: only event year known: 2024.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.Additional information was requested, and the following was obtained: on what date did the implant take place? (b)(6) 2024.Does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.No.Is the patient currently taking currently taking steroids / immunosuppressive drugs? patient was prescribed prednisolone after surgery to help with the edema.Did the patient have any pre-existing dysphagia or other conditions (other than gerd)? no.Was there any hiatal or crural repair done at the same time as the implant? was mesh used at time of implant? yes, hiatal hernia was repaired and mesh was used.At the time of removal, was the device found in the correct position/geometry at the time of removal? yes.Have the symptoms resolved since the device was explanted (no answer) ¿ what was the date of implant? (b)(6) 2024 (removed (b)(6) 2024).What is the device lot number? do not know.Was the device initially effective in controlling reflux? yes.Were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? did the patient have any other surgeries in the area? no.What is the management plan? is device removal scheduled? is a replacement linx or fundoplication planned? device was removed on (b)(6).When and if the explanation takes place can we ask that the procedure gets video recorded and the video shared? already completed.When and if the linx device is removed, may we ask that the device be returned for analysis? will inquire if kept.Did the patient have previous disorders? no.Is the patient suffering from any symptoms? 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 lxmc15 had issues during an unknown case.
Additional Manufacturer Narrative
(b)(4).Additional information was requested, and the following was obtained: were any events associated with the onset of symptoms (vomiting, retching, trauma, surgery)? patient consistently eating too fast.Did the patient have any other surgeries in the area? yes, hiatal hernia was repaired and mesh was used on (b)(6) 2024.Is a replacement linx or fundoplication planned? no.

• 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: 19359280
• Report Number: 3008766073-2024-00089
• Device Sequence Number: 17093348
• 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: 2024
• 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
• Report Date (Section B): 05/24/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 05/24/2024
• 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): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male