MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X EP SYSTEM V1.1.1; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-SYSTEM-111

Device Problem Electromagnetic Interference (1194)

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

Event Date 03/30/2022

Event Type  malfunction  

Event Description

During the procedure with the patient prepped, metal distortion was noted and the case was cancelled.The table was adjusted, the c-arm, monitor, iv poles, carts and booms were moved.Metal distortion would lower with everything moved away, but increased after several minutes with the equipment still moved away.The case was abandoned with no harm to the patient.

Event Description

This occurred during an atrial flutter ablation procedure.

Manufacturer Narrative

The collect logs were provided and reviewed.Review of the files show there were metal distortion errors regarding the prs-a becoming invalid.Adjusting the metal environment near the patient such as raising the flat detector may resolve the issue.Navigate to the prs setup screen and ensure all line items are green.If necessary, resetting metal baseline should resolve the issue.We understand your concerns and will take it under advisement.The software is functioning as designed.See ensite x ep system ifu, setup, system tab - metal sub-tab.

• Brand Name: ENSITE¿ X EP SYSTEM V1.1.1
• 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: 14015613
• MDR Text Key: 288615141
• Report Number: 2184149-2022-00095
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2022

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 Model Number: ENSITE-SYSTEM-111
• Device Lot Number: 8321596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 04/06/2022; 04/14/2022
• Supplement Dates FDA Received: 04/06/2022; 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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 Sex: Male
• Patient Race: White