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

Catalog Number LXMC17

Device Problems Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dysphagia/ Odynophagia (1815); Nausea (1970); Vomiting (2144); Hernia (2240); Weight Changes (2607)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 4/25/2024 b3: only event year known: 2023 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.Additional information was requested, and the following was obtained: the lot #27908 when was the initial linx implanted? -(b)(6) 2023 when was the device explanted? -(b)(6) 2024 where dilations performed? -(b)(6).How many dilations did the patient go through? -1 what are the dates of the dilations? -(b)(6) 2024 did the patient have an autoimmune disease? -no is the patient currently taking steroids / immunization drugs? -no did the patient have any pre-existing dysphagia or other conditions (other than gerd)? -paraoesophageal hernia how severe was the dysphagia/odynophagia before intervention? -dysphagia with nausea and vomiting was there any hiatal or rural repair done at the same time as the implant? -yes paraoesophageal hernia repair were there any other contributing factors that led to the removal of the device other than the reported dysphagia? -persistent nausea and vomitting and unintentional weightless what was the reason for removal of the linx device? -persistent nausea and vomitting and unintentional weightloss was the device found in the correct position/geometry at the time of removal? -n/a device has not yet been removed 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 Description

It was reported that a linx had to be explanted due to persistent nausea, vomiting and unintentional weight loss.

Manufacturer Narrative

(b)(4).Date sent: 5/9/2024 see attachment a manufacturing record evaluation was performed for the finished device 27908 number, and no non-conformances related to the malfunction were identified.Additional information was requested, and the following was obtained: explanted the patient yesterday without any complications.The patient's linx actually migrated up into the chest with a recurrent hiatal hernia.Patient was originally a small hiatal hernia, that underwent uneventful repair with mesh.Patient is doing well.Prior to linx placement, did the patient have an egd, ph, and manometry studies done? if yes, could you please share the results? yes.It is attached to this email.The product code for lot number 27908 is lxmc17.

• Brand Name: 1.5T LINX, 17 BEADS
• Type of Device: 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: 19180706
• MDR Text Key: 341024081
• Report Number: 3008766073-2024-00073
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005370
• UDI-Public: 00855106005370
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: LXMC17
• Device Lot Number: 27908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 100 KG