MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X SOFTWARE V3.0.2; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-SW-3.0.2
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product's lot number could not be obtained; therefore, the primary di number is provided (d4), but full udi information is not available.
Event or Problem Description
During the supraventricular tachycardia procedure using ensitex v3.0.2, display issues resulted in a procedural delay.It was noted that se points could not be collected.The catheter showed green on ensite gui and the catheter was out of the sheath.Troubleshooting included trying a different se point, replacing the catheter, restarting the system, and restarting the study all with no resolution.The se cable was reconnected, the catheters were deleted and auto-populated, the se cable was moved to the se2 port on the amplifier, the dws was reconnected to the amplifier via software, and the amplifier was power cycled, all with no resolution.Switched to voxel mode and confirmed voxel/geo creation with the ablation catheter and returned to navx mode which resolved the issue.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.Review of the collect logs was unable to confirm the reported event.The event date was not contained in the logs provided.Abbott is unable to evaluate the product involved in this incident based on the information received.The cause of the reported incident could not be determined.

• Brand Name: ENSITE¿ X SOFTWARE V3.0.2
• Common Device Name: 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: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21730000
• Report Number: 2184149-2025-00064
• Device Sequence Number: 19870542
• Product Code: DQK
• UDI-Device Identifier: 05415067050014
• UDI-Public: 05415067050014
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K242016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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
• Operator of Device: Health Professional
• Device Model Number: ENSITE-SW-3.0.2
• Device Catalogue Number: ENSITE-SW-3.0.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown