MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE X SOFTWARE V3.0; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-SW-03

Device Problem Electromagnetic Interference (1194)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2023

Event Type  malfunction  

Event Description

Related manufacturing ref: 2184149-2023-00231.During a typical atrial flutter ablation procedure, a communication issue occurred and the procedure was cancelled.During the procedure, the amplifier encountered multiple disconnections, and higher than usual distortion that made it impossible to work in voxel mode.When switched to navx mode to move forward with case, distortion was higher than 3.Only after completely removing the x-ray, the system passed distortion.After that was done and after confirming that everything was connected, the system was unable to collect any magnetic data (no orange dot during the entire case).Check metal and baseline was performed, respiration was performed, prs dots were green, and the tactiflex dot was green.Se field scaling couldn¿t be completed as magnetic data could not be collected, and therefore no force was displayed on the catheter and the procedure was cancelled with no consequences to the patient.

Manufacturer Narrative

The reported event stated that "higher than usual distortion that made it impossible to work in voxel mode" occurred.We are unable to evaluate the product involved in this incident based on the information received.The cause of the reported electromagnetic interference and subsequent procedure cancellation remains unknown.

• Brand Name: ENSITE X SOFTWARE V3.0
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18245660
• MDR Text Key: 329469431
• Report Number: 2184149-2023-00232
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K231415
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-SW-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ENSITE¿ X AMPLIFIER.