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

Device Problems Device-Device Incompatibility (2919); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Anxiety (2328); Unspecified Respiratory Problem (4464); Alteration in Body Temperature (4568)

Event Date 04/20/2023

Event Type  Injury  

Event Description

I was receiving care for a neurological work up at the emergency room of (b)(6) medical center in (b)(6).The physician, dr.(b)(6), ordered an mri of the head/brain.I alerted him, nursing staff, and the radiology tech of my implanted linx device and gave them the implant card that states mri instructions.I was nervous regardless, but trusted them to make safe decisions regarding my care, especially in the neurological state i was in.I got to the mri machine and the tech knew i was nervous so he offered to slide the table up before the procedure so i could see the inside of the machine.As soon as the table slid up, i started experiencing excruciating pain- i felt like my chest was ripping apart and also felt internal heat.It felt like every organ in the region was being burnt and suffocated.The tech pulled me out of the machine very quickly and assessed me appropriately while getting me back to the physicians care as soon as possible.I was extremely scared and shook up and denied any further testing and requested to leave after the health care team started making jokes outside the door about how they are now "giving away free trauma scans".It was a very traumatizing experience.I'm left with an extra two bills because i elected to go to another hospital to make sure the device had not migrated.Personally, i am an emergency medicine and critical care registered nurse and i understand firsthand that accidents happen, but this was handled poorly which contributed to my terrorized reaction.Since the incident, i have been feeling pain and pressure in the les area- however, there are no linx surgeons near where i live any more.I'm happy to assist and answer questions.

• Brand Name: LINX
• Type of Device: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
• Manufacturer (Section D): TORAX MEDICAL INC.
• MDR Report Key: 16818152
• MDR Text Key: 314117099
• Report Number: MW5117064
• 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: 04/24/2023

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2023
• Patient Sequence Number: 1
• Treatment: 1 LITHIUM 1200MG X1; 1 PROPRANOLOL 80MG ; LEVOTHYROXINE 25MCG
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White