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

Catalog Number UNK LINX MAGNETIC IMPLANT

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

Patient Problems Dysphagia/ Odynophagia (1815); No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Event date: only event year known: 2018.Additional information: i do not have the exact date of the implant, i can check with the doctor.The symptoms below were not present before the implant.Pain worse with certain type of foods.Pain is acute and excruciating.Additional symptoms: wheezing and cough.I did not have an mri.I have night reflux causing respiratory issues.I am seeing a gastroenterologist and a pulmonologist who are running tests.During the last few weeks i had been prescribed prevacid, prednisone 20 mg, benzonatate 100 mg and ibuprofen 600.

Event Description

It was reported that they have the linx device implanted and has concerns.Painful at the beginning then it was fine.A couple of weeks ago, she noticed that when she eats, she has a sharp pain on the left side of the throat that slowly moves down to her chest.

Manufacturer Narrative

(b)(4).Additional information received: per the patient, an endoscopy today and they were trying to figure out why she is having the spasms.She was originally diagnosed with bronchitis.A ct-scan was done and showed pneumonia with infiltration as the doctors thinks.It is unknown if the patient symptoms are a result of the linx implant or respiratory issues she has recently experienced.She had antibiotics and has been sick for a couple of months and states her health has gone south since the linx.Based on the last communication received the patient was on prevacid, prednisone, benzonatate and ibuprofen.She confirmed that the only medication she is currently taking is nexium twice a day which was prescribed by the gi doctor.She continues to have difficulty in swallowing.She could not remember the exact implant date, but she thinks it was about a year and half ago.She will see her gi doctor next week and discuss the next steps.

Manufacturer Narrative

(b)(4).Corrected data: upon further review of the additional information, it cannot be determined if the symptoms and medication prescribed is a result of the device.Therefore, this event will be considered not reportable.

• Brand Name: UNK LINX MAGNETIC IMPLANT
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 8137580
• MDR Text Key: 130187203
• Report Number: 3008766073-2018-00217
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2018

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 Catalogue Number: UNK LINX MAGNETIC IMPLANT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 01/07/2019; 02/01/2019
• Supplement Dates FDA Received: 01/22/2019; 02/01/2019
• Patient Sequence Number: 1