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); Patient Device Interaction Problem (4001)

Patient Problems Apnea (1720); Vomiting (2144); Dizziness (2194); Hernia (2240); Syncope/Fainting (4411)

Event Date 02/17/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date: unknown; captured as awareness date.Exact implant day is unknown.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: what is the product code for the linx device? what is the lot number of the linx device? what was the exact implant date of the linx device? was the omeprazole 60mg over the counter or doctor prescribed? if the device is going to be explanted, what is the explant date? do we have permission to contact the implant and explant surgeon? if yes, please provide full name and contact information for the implant and explant surgeon? when we call the surgeon, they will ask for the patient¿s date of birth.What is your date of birth? 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 in (b)(6) 2020 patient had linx implanted and never got relief.First week after surgery, violent projectile vomiting.Has had 4 hiatal hernia repairs with mesh since procedure and is on omeprazole 60mg.Has post nasal drip, and is aspirating.Had barrett's esophagus - from before surgery.Has developed persistent cough, constantly and ruptures blood vessels in her eyes.Stops breathing at night - gasping for air.Has dumping syndrome also.Has had precancerous lesions removed and has hernia pressing on vagal nerve - she would pass out, dizzy.Paraoesophageal hernia.When she bends over - bile coming out nose and mouth.Had procedure at phoebe putney albany ga.The doctors keep telling the patient that it just takes time, so patient has appt with thoracic surgeon.Patient would like to know if her device is on recall.Referred patient to her surgeon for model and lot number for verification of status in linx recall.

• 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: kara ditty-bovard ; 4188 lexington avenue north; shoreview 55126 ; 6107428552
• MDR Report Key: 13652832
• MDR Text Key: 286448768
• Report Number: 3008766073-2022-00049
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• 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: 03/02/2022

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
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 03/02/2022
• 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