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

Model Number	ENSITE-SYSTEM-111
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem Description
This occurred during an atrial flutter ablation procedure.
Additional 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
• Common Device Name: 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
• Report Number: 2184149-2022-00095
• Device Sequence Number: 6301540
• Product Code: DQK
• UDI-Device Identifier: 05415067041722
• UDI-Public: 05415067041722
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 04/06/2022; 04/14/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 04/06/2022; 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: White