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

Patient Problems High Blood Pressure/ Hypertension (1908); Failure of Implant (1924); Pain (1994); Discomfort (2330)

Event Date 08/23/2023

Event Type  malfunction  

Event Description

An mri cervical spine was attempted for a patient with a linx reflux device implanted in 2018.Proper mri screening was performed and the implant was confirmed to be mr conditional for 1.5t.The patient validated this by presenting a blue implant card at the mri appointment.The patient also had successfully completed a prior mri lumbar spine in 2021.The technologists acted appropriately under all labelled requirements of the implant, including move the patient slowly into the machine and maintained communication with the patient between sequences.Midway through the exam, the patient alerted the technologist that she was feeling discomfort in her stomach.The patient admitted that she felt the discomfort as they were moving her into the scanner but didn't think anything of it at the time.The patient alerted the technologist because the pain did not resolve while in the machine.The mri study was terminated and the patient was slowly removed from the mri room into a nearby holding area.An rn from the adjacent urgent care was called over to mri to assess the patient.Patient was hypertensive and taken to urgent care for observation and later released after getting back to baseline.The surgeon's office that implanted the device was contacted immediately to coordinate urgent follow-up.The concern was that the linx device had migrated when the patient was moved into the mri machine.The patient was seen and expressed no new symptoms and that the pain that was felt during the mri was resolved.Out of precaution, an esophagram was still ordered to verify device placement.The esophagram was completed on (b)(6) 2023 and revealed a new gap between 2 components of the device, suspected of device failure.

• Brand Name: LINX REFLUX MANAGEMENT SYSTEM
• Type of Device: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
• Manufacturer (Section D): TORAX MEDICAL, INC.
• MDR Report Key: 18094378
• MDR Text Key: 327887340
• Report Number: MW5147926
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2023

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIEMENS AVANTO/AERA FIT 1.5T.
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White