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

Model Number LXMC17

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

Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Vomiting (2144)

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 12/19/2022 date of event: unknown, assumed 1st day of month that the event took place.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 batch number (b)(4), and no non-conformances were identified.Additional information was requested, and the following was obtained: do you have the linx product code? do you have the lot number and serial number (if applicable)? have you had any diagnostic testing done to address the symptoms you experienced while the device was implanted? if yes, what diagnostic testing were completed? can you share the results of the diagnostic tests? do you have an autoimmune disease? have you been prescribed medication by a doctor (not over the counter medication)? if yes, what is the doctor prescribed medication? are you currently taking steroids / immunization drugs? respondent answers: device was implanted on (b)(6) 2022.Model number lxmc17.Lot number 26632.Manufacturer torax medical inc.Hospital is (b)(6).Dr.(b)(6).17 bead 1.5 tesla.Gerd lxmc17.Have you had any diagnostic testing done to address the symptoms you experienced while the device was implanted? if yes, what diagnostic testing were completed? i have not any testing done since the device was implanted.I am about to have an ultrasound and a brain mri over the next few weeks.Can you share the results of the diagnostic tests? no results to share.Do you have an autoimmune disease? no.Have you been prescribed medication by a doctor (not over the counter medication)? yes i take medication for chronic pain and high blood pressure.Here are the meds: percocet 5mg 4 times daily.Colindine twice daily.Methadone twice daily.Ambien once daily.Folic acid 1 daily.Vitamin day 1 weekly.Testosterone every other week.If yes, what is the doctor prescribed medication? are you currently taking steroids / immunization drugs? no steroids.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 the patient had device placed in (b)(6) of 2022 and has been symptom free until last evening where he stated he experienced regurgitation shortly after falling asleep.He wanted to know if his product failed.Erd nurse stated it is not uncommon to have some break through symptoms then referred them to their personal physician for cause and treatment.

• Brand Name: 1.5T LINX, 17 BEADS
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• Manufacturer Contact: kate karberg ; 4188 lexington avenue north; shoreview ; 3035526892
• MDR Report Key: 16003681
• MDR Text Key: 308392778
• Report Number: 3008766073-2022-00244
• Device Sequence Number: 1
• Product Code: LEI
• 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
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2024
• Device Model Number: LXMC17
• Device Catalogue Number: LXMC17
• Device Lot Number: 26632
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1