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

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

Patient Problems Headache (1880); Muscle Spasm(s) (1966); Pain (1994)

Event Date 01/04/2019

Event Type  Injury  

Event Description

I had a linx medical device placed and hernia repair.I was told i could still vomit as i have chronic migraines.I am unable to vomit and now i have excruciating pain from the device and esophageal spasms.I have general atypical dystonia on all my voluntary muscles which my surgeon knew, and protein deficiency.I have had pulmonary emboli, and dvts, i have copd.This surgery was not successful and added to my chronic pain.I am still taking 40 mg of nexium x2 every day and have gerd.Fda safety report id# (b)(4).

• Brand Name: LINX
• Type of Device: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
• Manufacturer (Section D): TORAX MEDICAL, INC.
• MDR Report Key: 10078520
• MDR Text Key: 191961813
• Report Number: MW5094629
• Device Sequence Number: 1
• Product Code: LEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 54 YR
• Patient Weight: 86