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

Model Number	ENSITE-SW-03
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, a shift occurred resulting in cancellation of the procedure.There was a shift in ensitex in voxel mode; alignment could not be done and could not compensate the shift.Prs-a and prs-p sensors were correctly placed and respiration was done multiple times which did not resolve the issue and the procedure was cancelled.
Additional Manufacturer Narrative
Additional information: g3, h2, h3 the case study, and collect logs were provided and reviewed.The reported event stated that "a shift occurred resulting in cancellation of the procedure" occurred.Review of provided files confirmed the issue occurred.The study showed catheters shifted outside the cs, la, and laa.The shifts occurred in relation to frequent irregular respiration rejection.It is recommended to remove any metal that may be causing potential metal distortion, reset the metal baseline or begin a new study.See ensite x ep system ifu, setup, system, prs sub-tab.
Additional Manufacturer Narrative
Udi related data quality updates only.Additional information: d4, g3, g6, h2, h11.The product's lot number could not be obtained; therefore the primary di number is provided (d4), but full udi information is not available.

• Brand Name: ENSITE X SOFTWARE V3.0
• Common Device Name: ENSITE X SOFTWARE V3.0
• 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: 18003158
• Report Number: 2184149-2023-00215
• Device Sequence Number: 12672098
• Product Code: DQK
• UDI-Device Identifier: 05415067047854
• UDI-Public: 05415067047854
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup,Followup
• Report Date (Section B): 07/22/2024

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: 10/25/2023
• Supplement Date Received by Manufacturer: 10/25/2023; 01/11/2024; 07/09/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 10/25/2023; 01/16/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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