MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X SOFTWARE V3.1; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-SW-3.1
Medical Device Problem Codes	Electromagnetic Interference (1194); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
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 paroxysmal supraventricular tachycardia procedure, issues with the software resulted in a procedural delay.The electrode kit was applied to the patient, the ablation catheter and the mapping catheter were inserted into the cardiac cavity and connected to ensite.It was noted that distortion meter on the dws exceeded the limit (ii), turned red, and froze.The navigation displays of the catheters also froze.No error message was displayed.The sheath was moved, the field frame was adjusted, the location of the prs-a was checked with a touch, each prs cable was reconnected, the cables of both catheters were reconnected, the ensite was restarted, and the ablation catheter was replaced.The ensite was restarted again and the distortion meter and navigation display freeze were resolved.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.Two case studies were provided for review.Review of the study showed the metal distortion threshold was increased by the user over 1 prior to the event.Adjusting the threshold allows 3d point collection however with more metal distortion error.Exporting the magnetic location data showed that the prs-a position did start slightly changing at the time of the event just enough to cause the distortion meter to go over the threshold.A workaround is to either reset the metal baseline or try adjusting the prs-a position/orientation slightly to see if metal distortion decreases below ii.The software is functioning as designed.

• Brand Name: ENSITE¿ X SOFTWARE V3.1
• 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: 21179889
• Report Number: 2184149-2025-00012
• Device Sequence Number: 4300605
• Product Code: DQK
• UDI-Device Identifier: 05415067049704
• UDI-Public: 05415067049704
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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-3.1
• Device Catalogue Number: ENSITE-SW-3.1
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 07/02/2025
• 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