MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X SYSTEM; Computer, diagnostic, programmable

Model Number ENSITE-SYSTEM-201

Device Problem Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2024

Event Type  malfunction  

Event Description

During a supraventricular tachycardia procedure, an unexpected shutdown occurred which delayed the procedure.Using navx mode v3.0.1, when mapping, creating and editing model, the system became slow and the dws shut down without any alerts being displayed.After shutting down, the red light on the dws's power button lit up three times and the beep sounded, which occurred repeatedly.The power outlet location was changed, and it was rebooted.Since it was rebooted successfully, the procedure continued, but under the same circumstances, this time it shut down without slowing down.The dws rebooted by disconnecting everything other than the power supply and restarting it, and the procedure continued.When the procedure resumed and rf delivery was performed, it shut down again.It was rebooted a third time the same way it was the second time.However, it did not reboot so fluoroscopic images and the recording system were used to check the location and effect of the rf delivery.The procedure was completed without replacing the ensite x with no consequences to the patient.

• Brand Name: ENSITE¿ X SYSTEM
• Type of Device: 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19165098
• MDR Text Key: 340868441
• Report Number: 2184149-2024-00079
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067046666
• UDI-Public: (01)05415067046666(10)10005806
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K221213
• 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
• Report Date: 04/23/2024

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
• Device Operator: Health Professional
• Device Model Number: ENSITE-SYSTEM-201
• Device Lot Number: 10005806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2024
• Initial Date FDA Received: 04/23/2024
• Date Device Manufactured: 10/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1