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

Model Number	ENSITE-SW-3.1
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a premature ventricular contraction procedure, there was a crash on the display workstation resulting in a 20 minute delay.When connecting a new tactiflex catheter to the amplifier.The display workstation showed an unexpected error, and the study closed itself.The study could not be restarted until the tactiflex se was disconnected.This was the first time using the display workstation after performing the update to v3.1.The procedure was completed in navx mode with a non-se catheter with no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6, h11.The reported event stated that "when connecting a new tactiflex catheter to the amplifier.The display workstation showed an unexpected error, and the study closed itself.".Review of the collect logs verified the unexpected shutdown occurred.In the logs, the catheter was not recognized as an ablation or se catheter leading to the crash.The root cause was the tactiflex license being out of date.The tactiflex will not be recognized on a system running v3.1 with the v3.0 tactiflex plug in module.It is recommended to upgrade the tactiflex plug-in module to 3.1.

• Brand Name: ENSITE¿ X SOFTWARE V3.1
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20786806
• Report Number: 2184149-2024-00201
• Device Sequence Number: 6989582
• Product Code: DQK
• UDI-Device Identifier: 05415067049704
• UDI-Public: 05415067049704
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/24/2025

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: 11/06/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 02/24/2025
• 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