MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE¿ X DISPLAY WORKSTATION; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

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	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial tachycardia procedure, the magnetic sensor of the catheter did not respond intermittently and was not stable resulting in a delay.The cable and catheter were exchanged with no resolution, but the issue was resolved by restarting the system.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: g3, h2, h3 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.
Additional Manufacturer Narrative
**udi related data quality updates only**.

• Brand Name: ENSITE¿ X DISPLAY WORKSTATION
• Common Device Name: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• 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 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18117586
• Report Number: 2184149-2023-00224
• Device Sequence Number: 12516571
• Product Code: DQK
• UDI-Device Identifier: 05415067037725
• UDI-Public: (01)05415067037725(21)19291274(10)8296158
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K212061
• 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-DWS-1.1
• Device Catalogue Number: ENSITE-DWS-1.1
• Device Lot Number: 8296158
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 01/26/2024; 06/12/2024; 07/10/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/31/2024; 06/19/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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
• Patient Sex: Unknown