MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE¿ X SOFTWARE; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number AFD-ENSITE-SW

Device Problem Electromagnetic Interference (1194)

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

Event Date 09/27/2023

Event Type  malfunction  

Event Description

During patient preparation, and while attempting to begin the procedure in voxel mode, it was not possible to do "set metal baseline" in ap, rao or lao.The height of the bed was changed, and the study was closed and a new one opened, but the issue was not resolved, and the procedure was cancelled.

Manufacturer Narrative

The collect logs were provided and reviewed.Review of the files indicates the prs status was invalid due it not being in a stable position.Therefore, it doesn't allow set metal baseline.However, the software is functioning as designed.The cause for the reported interference remains unknown.

• Brand Name: ENSITE¿ X SOFTWARE
• Type of Device: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17902378
• MDR Text Key: 325234864
• Report Number: 2184149-2023-00204
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AFD-ENSITE-SW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2023
• 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