MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE X SOFTWARE V2.0.1; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-SW-2.0.1

Device Problem Electromagnetic Interference (1194)

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

Event Date 06/20/2023

Event Type  malfunction  

Event Description

During an atrial fibrillation ablation procedure, troubleshooting to attempt to resolve distortion issues resulted in a procedural delay.The distortion level was reasonable during the initial part of the procedure.After approximately 30 mins without any apparent change to the magnetic environment and no movement in x-ray or table height, the distortion was above the threshold that would allow mapping.The x-ray detector was moved away from the patient and the view or angle was altered, but the distortion did not improve.The ablation was continued and without any change to the environment, the distortion returned to within normal limits.The procedure was completed successfully but the distortion caused delays in ablation due to loss of the vector on the ablation catheter.

Manufacturer Narrative

Additional information: d9, g1, g3, g6, h2, h3, h6.The device was not returned for investigation.The study data and collect logs have been requested, but not received.No investigation is possible without the requested data.Based on the information received, the cause of the reported issue remains unknown.

• Brand Name: ENSITE X SOFTWARE V2.0.1
• 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: 17266126
• MDR Text Key: 318497387
• Report Number: 2184149-2023-00131
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K202066
• 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: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-SW-2.0.1
• Device Catalogue Number: ENSITE-SW-2.0.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2023
• 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