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

Model Number	ENSITE-SW-03
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
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
Related manufacturing reference: 3008452825-2024-00522.During the supraventricular tachycardia procedure, communication issues resulted in a procedural delay.While using ensite x v3.0.1 in voxel mode, a tacticath se was connected to the ensite x amplifier with an se cable to se1 or se2 on the amplifier, and the system immediately displayed, "unexpected error" and the study was automatically closed.The amplifier, dws, and tactisys were all restarted but the issue was not resolved.The catheter was replaced but the issue persisted.The procedure was completed using the second catheter in navx mode and without connecting the se cable of the catheter to the amplifier, without magnetic navigation.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Review of the files determined the root cause was a corrupt catheter database.The issue was reproduced using the same database on a new system with the same conditions.It is recommended to replace the dws and reinstall the software.

• Brand Name: ENSITE X SOFTWARE V3.0
• 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 north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20229986
• Report Number: 2184149-2024-00160
• Device Sequence Number: 3393710
• Product Code: DQK
• UDI-Device Identifier: 05415067047854
• UDI-Public: 05415067047854
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K231415
• 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): 11/21/2024

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-03
• Device Catalogue Number: ENSITE-SW-03
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 11/21/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown