MAUDE Adverse Event Report: TORAX MEDICAL, INC. UNK LINX MAGNETIC IMPLANT; ANTI-REFLUX IMPLANT

Catalog Number UNK LINX MAGNETIC IMPLANT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Vomiting (2144); Choking (2464); Weight Changes (2607); Speech Disorder (4415); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Exact date is unknown.Device was implanted in 2019.First day of year and first day of month is assumed.Exact date is unknown.Device was explanted in 2021.First day of year and first day of month is assumed.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: do we have permission to reach out to your surgeon to ask the below questions? if yes, please provide your surgeons name and email address.When we contact them, they will ask for you date of birth.What is your date of birth? the below questions will go to your surgeon.What is the product code of the linx device? what is the lot number? what was the exact implant date? what was the exact explant date? what test were performed to determine that the ¿device was not opening and closing as it was supposed to¿ was there any pre implant motility testing? if yes, please share the results to productcomplaint1@its.Jnj.Com.Is the surgeon aware of the patients¿ issues? has the patient looked to the surgeon for treatment? 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 while the patient had the linx device she suffered and is still suffering from the side effects of the device.Patient indicated that her voice has been destroyed, that everything she ate she threw up.Patient stated that her doctor stated that the device was no opening and closing as it was supposed to and that is why she was having all of her problems.Patient stated that she was hospitalized about five times, she was throwing up food and coughing up stuff she doesn¿t know, it has destroyed her voice, she still feels like something is in her throat, she can¿t burp since the device was installed patient stated she¿ll choke trying to burp.Patient stated she has lost ¿like 70 pounds¿.Patient stated she so miserable and feels like her life will never be the same.

Manufacturer Narrative

(b)(4).Date sent: 11/29/2022.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.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• 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, MN ; 3035526892
• MDR Report Key: 15640724
• MDR Text Key: 302112337
• Report Number: 3008766073-2022-00206
• 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,Followup
• Report Date: 11/29/2022

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: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Disability