MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X EP SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-SYSTEM-01

Device Problem Application Program Problem (2880)

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

Event Date 04/13/2022

Event Type  malfunction  

Event Description

During an atrial fibrillation procedure, the catheter froze multiple times and was not moving at excessive speed.The procedure was completed with no consequences to the patient, however a delay occurred due to catheter freezing.

Manufacturer Narrative

Results of the investigation are inconclusive as nothing was retuned for review.However, review of the ensite system shows that se catheters freeze and electrodes turn red when either the magnetic data is invalid or the se catheter is outside of the motion box.In either case, the catheter location cannot be updated and it will appear stationary.The cause of the reported incident could not be conclusively determined.

• Brand Name: ENSITE¿ X EP SYSTEM
• 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: 14244685
• MDR Text Key: 290465645
• Report Number: 2184149-2022-00111
• 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,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ENSITE-SYSTEM-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2022
• 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