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

Device Problem Electromagnetic Interference (1194)

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

Event Date 07/13/2023

Event Type  malfunction  

Event Description

During a premature ventricular contraction procedure using ensite x in voxel mode, interference issues resulted in troubleshooting measures that caused a procedural delay.The mode was switched to navx and the procedure was successfully completed with no adverse consequences to the patient.It was noted that there were no magnetics on ensite x.The system was rebooted four times, and the field frame cable was reseated multiple times, without resolution.It was verified that there were no bent pins.The procedure was completed using navx mode with no adverse consequences to the patient.

Manufacturer Narrative

Based on the information received, the cause of the reported interference and subsequent delay remains unknown.

• Brand Name: ENSITE¿ X SOFTWARE
• 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: 17503720
• MDR Text Key: 320865301
• Report Number: 2184149-2023-00160
• 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: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2023
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Ethnicity: Hispanic