MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE X EP SYSTEM SURFACE ELECTRODE KIT (5PK US); ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number	ENSITE-SEK-5-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an svt procedure using the ensite x system in navx mode, communication issues were noted which caused delays to treatment.It was noted that there were no ekg signals displayed, only a pink line, on the ensite computer but the recording system did have ekg signals.There were no error messages displayed on the system and the patches were able to be validated successfully.The ekg and patch connections to the surface link and the amplifier were checked.It was the noted that the signals would appear when the right leg patch was disconnected but they would disappear when connected again.The right leg patch was replaced, the system was rebooted and a new study was started with no resolution.The ekg cable was replaced with no resolution.The surface link was replaced with no resolution.A new reference patch was put on the patient and the ekg signals showed up immediately and the issue was resolved.Revalidation was done but the system would not allow that due to a left leg patch issue so the left leg patch was replaced as well.The system was rebooted and a new study was started.This was successful and the procedure was started appropriately.Later in the procedure, some error messages were displayed on the screen and the case was exited.The message read: "unexpected error occurred.Application exited" and "destroyed while thread is still running".The system was rebooted and a new study was started.The procedure continued without any further issues.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
One ensite x surface electrode kit system reference electrode was received for evaluation.The left leg patch was also returned.The system reference electrode read as an open circuit due to a fractured wire in the connector socket.The left leg patch displayed continuity with no open circuits detected.In addition, the patch was able to be validated with no anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: ENSITE X EP SYSTEM SURFACE ELECTRODE KIT (5PK US)
• Common Device Name: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16454514
• Report Number: 3008452825-2023-00065
• Device Sequence Number: 5875589
• Product Code: DQK
• UDI-Device Identifier: 05415067032379
• UDI-Public: 05415067032379
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K083328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2023

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 Expiration Date: 04/30/2024
• Device Model Number: ENSITE-SEK-5-01
• Device Catalogue Number: ENSITE-SEK-5-01
• Device Lot Number: 8751804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/10/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown