MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X SOFTWARE LICENSE; Computer, diagnostic, programmable

Model Number ENSITE-TFM-03

Device Problem Application Program Version or Upgrade Problem (2881)

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

Event Type  malfunction  

Event Description

During the pulmonary vein isolation ablation procedure, software issues with the first two catheters used resulted in a procedural delay.After a tactiflex ablation catheter was plugged into the amplifier, an alert came up stating that the ablation catheter was not recognized.The amplifier was rebooted and the same alert came up.A new tactiflex ablation catheter was opened and attempted at use but the same alert was seen.Recently the software on the ensite x system was upgraded to ver.3.0.1 software.All of the steps to the upgrade were followed but, the tactiflex ablation catheter upgrade was not working properly.A tacticath ablation catheter was opened and the procedure was finished with no adverse consequences to the patient.

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.

• Brand Name: ENSITE¿ X SOFTWARE LICENSE
• Type of Device: 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18006842
• MDR Text Key: 326609199
• Report Number: 2184149-2023-00216
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-TFM-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 88 KG