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

Catalog Number	LXMC17
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent 10/16/2024 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: how was the migration of the device diagnosed (chest x-ray, esophageal line at explant)? are there images available that shows the migration? did the patient have a hiatal hernia at the time of implant? if yes was this repaired at this time of implant? does the patient have a re-occurring hernia now? if yes, did the position of the device change based on the hernia reoccurring? 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 there was removal of linx device.Reason for removal was the stomach herniated through the linx device.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/23/2024.Additional information was requested, and the following was obtained: how was the migration of the device diagnosed (chest x-ray, esophageal line at explant)? the migration was noted on xr, esophagram on (b)(6) 2024 ¿hiatal hernia through the linx device¿.Are there images available that shows the migration? yes @ adventhealth, daytona.Did the patient have a hiatal hernia at the time of implant? if yes was this repaired at this time of implant? the patient had a paraesophageal hernia at the time of the implant which was repaired and bio a mesh placed on (b)(6) 2024.Does the patient have a re-occurring hernia now? if yes, did the position of the device change based on the hernia reoccurring? the patient has since had 2 more operations.(b)(6) 2024: diagnostic laparoscopy, laparoscopic 22-frech gastrostomy tube placed, lysis of adhesions and (b)(6) 2024 laparoscopic repair of recurrent paraesophageal hernia with dor anterior fundoplication partial, explant magnetic sphincter augmentation device, lysis of adhesions, repair of gastrostomy with omental patch.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• 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: 20460538
• Report Number: 3008766073-2024-00144
• Device Sequence Number: 21046813
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: LXMC17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 10/23/2024
• 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