MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X DISPLAY WORKSTATION; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-DWS-1.1
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, a communication issued occurred causing a delay.The ensite x was used with farawave navx mode, and communication between the amplifier and dws was interrupted toward the end of post mapping after pulse field ablation.A "communication failure" alert pop-up was displayed, and the electric potential waveform became purple flat.Amplifier reconnect and reset amplifier were performed from the dws side, but the alert persisted.During that time, the lamp next to the amplifier power button was flashing green, and the lamp at the optical cable port on the dws was not lit.The lamp on the amplifier side was lit orange.The optical cable was exchanged, the cables on the panels of the amplifier were removed and the power of dws and amplifier were turned off.The dws was then started up, and the amplifier was started up as per proper instructions, but communication was not restored.The amplifier power lamp was flashing green and the dws optical cable lamp remained off.Dws restart was performed 4 times, but communication was not restored.Therefore, it was not possible to continue navigation using ensite, and it was switched to ablation under fluoroscopy.The procedure was completed without replacing the ensite x dws with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: b5, d10.
Event or Problem Description
Related manufacturing ref: 2184149-2025-00070, 2184149-2025-00071.Additional inspection at the distributor determined that the cause of the communication issue was due to the fiber optical cables having deteriorated over time and communication was no longer possible.
Additional Manufacturer Narrative
Additional information: g3, h2, h3, h6.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information received, the cause of the reported communication issue and subsequent delay remains unknown.

• Brand Name: ENSITE¿ X DISPLAY WORKSTATION
• 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: 21710425
• Report Number: 2184149-2025-00060
• Device Sequence Number: 10071528
• Product Code: DQK
• UDI-Device Identifier: 05415067037725
• UDI-Public: (01)05415067037725(10)8224431
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 04/21/2025

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-DWS-1.1
• Device Catalogue Number: ENSITE-DWS-1.1
• Device Lot Number: 8224431
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 04/07/2025; 04/21/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/07/2025; 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENSITE VELOCITY¿ FIBER OPTIC CABLE DUPLEX.; FIBER OPTIC CABLE - DUPLEX.
• Patient Sex: Unknown