MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE X EP SYSTEM SURFACE ELECTRODE KIT (5PK OUS); COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-SEK-5-I-01

Device Problem Communication or Transmission Problem (2896)

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

Event Date 04/03/2023

Event Type  malfunction  

Event Description

During the atrioventricular reentrant tachycardia procedure, there was no connection with the amplifier resulting in a delay.All connections checked and a new fiber optic cable was plugged in.The patches were validated and both the ensite x system and amplifier systems were turned off and, on several times, even with different sequences.After all these attempts a new reference patch was plugged in and the issue was resolved.The procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

Additional information: d9, g3, h2, h3.One ensite x surface electrode kit system reference electrode was received for evaluation.The system reference electrode was connected to an adaptor cable to aid with electrical testing.When tested for open circuits, the patch did not display continuity between the distal electrode and the respective connector while stable and during manipulation.Additional patches were able to successfully attach to a cable which was used during electrical testing.The patches were electrically tested for open circuits.The patches were electrically tested while stable and manipulated.The patches displayed continuity between distal electrode and the respective proximal connector pin with no open circuits detected.The connector was opened and an internal wire in the connector socket was found to be fractured.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The system reference electrode read as an open circuit due to a fractured wire in the connector socket.

• Brand Name: ENSITE X EP SYSTEM SURFACE ELECTRODE KIT (5PK OUS)
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: 16709998
• MDR Text Key: 312988305
• Report Number: 3008452825-2023-00157
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K202066
• 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
• Report Date: 06/16/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: ENSITE-SEK-5-I-01
• Device Lot Number: 8820055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/10/2023
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1