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

Catalog Number LXM15

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Weight Changes (2607); Insufficient Information (4580)

Event Date 02/01/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 2/16/2024.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.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.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: does the patient have any of the allergies to metals? if so, what test have been done to test for metal allergies.Is the patient currently taking currently taking steroids / immunosuppressive drugs? did the patient have any pre-existing dysphagia or other conditions (other than gerd)? was there any hiatal or crural repair done at the same time as the implant? was mesh used at time of implant? what was the reason for removal of the linx device? at the time of removal, was the device found in the correct position/geometry at the time of removal? have the symptoms resolved since the device was explanted? 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 implant was surgically removed.Initially implanted (b)(6) 2020.Patient male, 30 years old.Unknown reason.

Manufacturer Narrative

(b)(4) date sent: 4/11/2024 investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device 20404 number, and no non-conformances related to the malfunction were identified.

Manufacturer Narrative

(b)(4).Date sent: 4/24/24 additional information was requested, and the following was obtained: 1.What was the reason for the explantation? indication: burning mouth syndrome condition after laparoscopic anterior hiatoplasty with placement of an anti-reflux magnetic band (linx), esophagogastroduodenoscopy on (b)(6) 2020 for small axial hiatal hernia, progressive reflux esophagitis with tongue burning, cardiaspasm, volume reflux condition after tonsillectomy 03/2020 condition after folic acid deficiency gastric metaplasia of the distal oesophagus penicillin allergy therapy: conservative treatment no improvement in symptoms after linx, rather worse, cannot sleep, cannot eat, weight loss, complains of pain does not take acid blockers, takes psychotropic drugs 2.Was the patient undergoing an mri? no 3.Could the implant be explanted without complications? if not, what complications occurred? was the patient harmed in the process? yes 4.What alternative treatment was the patient provided with? the hemifundoplication from the first operation was left in place 5.Can the implant be sent in for examination? (a declaration of consent from the patient is required for this) it was disposed of 6.Do you have any further information that could be helpful for the examination? no.

• Brand Name: LINX 1.5T 15 BEAD OUS
• 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: 18725872
• MDR Text Key: 335712167
• Report Number: 3008766073-2024-00037
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2022
• Device Catalogue Number: LXM15
• Device Lot Number: 20404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 04/11/2024; 04/23/2024
• Supplement Dates FDA Received: 04/11/2024; 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2018
• 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: 30 YR
• Patient Sex: Male