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

Model Number ENSITE-SW-03

Device Problems Display or Visual Feedback Problem (1184); Application Program Problem (2880)

Patient Problems Cardiac Perforation (2513); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2023

Event Type  Injury  

Event Description

During an atrial flutter procedure, the deflection indicator was incorrect.There was a pericardial effusion that was indicated after the last vein isolation.The procedure stopped when the issue was identified.

Manufacturer Narrative

Corrected data: b5, further information confirmed that the procedure was successfully completed with no adverse patient consequences.There was no pericardial effusion.The reported event stated that the force arrow displayed incorrectly.Review of the ensite system confirms the event occurs due to a known software anomaly.

Event Description

During an atrial flutter procedure, the deflection indicator was incorrect.However, the procedure was successfully completed with no patient consequences despite this issue.

Manufacturer Narrative

The corrected product is ensite x software v3.0, model: ensite-sw-03.

• Brand Name: ENSITE X SOFTWARE V3.0
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• 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 ; AS
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17726542
• MDR Text Key: 323146727
• Report Number: 2184149-2023-00182
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K231415
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-SW-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 09/12/2023; 03/18/2024
• Supplement Dates FDA Received: 10/02/2023; 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1