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

Catalog Number LXMC15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pyrosis/Heartburn (1883); Pain (1994); Abdominal Distention (2601)

Event Date 01/04/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4) date sent; 1/30/2024 b3: unknown; captured as awareness date 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: the event description says ¿patient never got relief." never got relief from what symptoms? what is the exact date of the implant? what was the telsa strength of the mri? what is the product code for the device? what is the lot number of the deceive? was there a dilation completed? when/if the device is ever explanted, please let us know and reference the (b)(4).Additional information received: electrical current increased hr can't wear a bra 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: please provide more details about ¿electrical current¿ and ¿increate of hr¿ additional information received: lxmc15, lot number: 21919? customer said she had called many times since the implant was implanted and removed.She wanted to speak about how it has impacted her life.The lot number is not on the list of recalls.The customer stated this product has ruined my life.Can't vomit anymore.Gest gas and bloating and have to take 8-10 medications for it a day,.Heart palpitations.Can't wear a bra, feels like plugged into an electrical outlet.Scar tissue that is pushing against my vagas nerve.Has to take xanax at night to stop the feeling of having to pee when she don't even have to pee, just the feeling.It was a horrible experience, acid reflux is blocked in my stomach.Big amount of problems.It was implanted in 2019, and the problems started probably nov/oct.Of that year." additional information was requested, and the following was obtained: are you taking any prescribed medication (from a doctor) that is in direct relation to the linx device? nerve blockers, celebrex and xanax all for vagus nerve damage 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 patient had a linx placed 3/2019.Patient never got relief.Cannot belch or vomit and has gas pain when wearing a bra.Has had mri and scopes and nothing was found.Patient wants implant removed and surgeon will not remove.

Manufacturer Narrative

(b)(4).Date sent: 2/9/2024 additional information received: as to your basic questions, i am uncertain why you think i have the ability to approve you getting into my medical records when you do not believe i have said ability to answer basic health conditions concerning my health.Explant was around 2021, i still have gas and bloating but not as extreme as before when i couldn¿t leave house or refrain from releasing gas in front others leading to isolation.No reflux since implant or explant, nothing comes up including when i¿ll and need to vomit.Not much testing done prior to explant due to the fact that i wanted it out-which is the way it should be-took me a year or more to find surgeon willing to remove the device and he probably did so due to the fact i was at the end of my rope and in tears.Linx has ruined my quality of life, most likely due to scarring near vagus nerve.If you have questions you feel i cannot answer please feel free to reach out to the fda, i¿m sure you are more likely to get someone to answer more than me.I was lucky to find a surgeon to remove the linx, but i am left seeing specialists in search of answers to fix what side effects i have been left with, the electrical current and chronic pain throughout my body being the worst.I would not wish my suffering upon anyone.

• Brand Name: 1.5T LINX, 15B
• 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: 18606866
• MDR Text Key: 334101303
• Report Number: 3008766073-2024-00020
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 07/18/2022
• Device Catalogue Number: LXMC15
• Device Lot Number: 21919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2018
• 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