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 Pyrosis/Heartburn (1883); Pain (1994); Burning Sensation (2146)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only event year known: 2022.Additional information was requested, and the following was obtained: in order to better understand your medical history and what has occurred, may we have your permission to contact dr.(b)(6)? if yes, could you please provide the contact information? answer= dr.(b)(6) implanted my linx device in (b)(6) of 2018.I started valium 10mg a day in 2019 for globus sensation and burning mouth syndrome.The pain is ongoing.I'm in pain management now and have tried at least 6 different medications.(b)(6).Additional information received: spoke to (b)(6) on the phone.She said that dr.(b)(6) has been on medical leave for 2 years and is looking to retire.I asked if i could get her email address so we could send her a list of questions.She said she would look up the information for the patient and see if she can answer our questions.Dob for patient is (b)(6).Email for (b)(6).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: the list of questions below are for the patient (b)(6), date of birth is (b)(6).What is the product code of the linx device that was implanted? what was the exact date of the implant? what is the lot number of the device that was implanted? if the explant is scheduled, please let us know the explant date.Have any motility studies been completed for this patient? if yes, could you please share the results.Has an esophagram been completed? what test have been complete for the patient¿s symptoms (ph monitoring, etc.)? could you please share the results? please provide any additional testing that has been completed for the patient.

Event Description

It was reported that the patient had a linx device implanted for esophagitis, gastritis, and gerd.For the past two and a half years she has experienced daily a globus sensation and a burning sensation in her mouth, throat, and on her tongue.Onset begins in the morning following taking her medication.She currently uses belbuca, valium, and neurontin and has been in pain management for the past year.She plans to find another medical professional to treat her.

• 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: 13579889
• MDR Text Key: 289876068
• Report Number: 3008766073-2022-00038
• 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: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• 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
• Date Manufacturer Received: 02/04/2022
• 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
• Patient Age: 56 YR