MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE¿ X EP SYSTEM SURFACE ELECTRODE KIT (1 PK JP); ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number ENSITE-SEK-1-01

Device Problem Communication or Transmission Problem (2896)

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

Event Date 03/13/2023

Event Type  malfunction  

Manufacturer Narrative

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.Based on the information received, the cause of the reported communication issue could not be conclusively determined.

Event Description

Related manufacturing ref: 3008452825-2023-00133.During the atrial tachycardia procedure, on the non-abbott (nihon kohden rmc4000 catheter recording) system, noise was noted in the intracardiac electrocardiogram.There was no issue with the ensite x.The tactiflex ablation catheter se was replaced to resolve the issue.During the procedure the ensite x validation was not successful.The ref patch and the light blue module patch, the other 5 patches, and the right leg electrode were replaced in this order, but the problem persisted.The ensite amplifier and display workstation were rebooted, and the optical cable between the amplifier and display workstation were replaced, but the issue persisted.Removing the right leg electrode resolved the issue.The procedure was completed with no adverse consequences to the patient.

• Brand Name: ENSITE¿ X EP SYSTEM SURFACE ELECTRODE KIT (1 PK JP)
• Type of Device: 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: 16678338
• MDR Text Key: 312686142
• Report Number: 3008452825-2023-00134
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083328
• 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: 04/04/2023

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: 04/30/2024
• Device Model Number: ENSITE-SEK-1-01
• Device Lot Number: 8753300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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
• Treatment: TACTIFLEX ABLATION CATHETER SE