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

Model Number	ENSITE-DWS-01
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Electromagnetic Interference (1194); Application Program Problem (2880); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an ensite x pulmonary vein isolation and typical flutter with ensite x in navx and voxel mode, a prolonged procedure occurred.All the catheter and the guidewire were placed in non-fluoro mode and a model was taken of the right atrium and coronary sinus in navx mode.In navx mode, there was a lot of respiration related catheter movement and a map shift occurred.The ensite x's magnetic field is interfering with the defibrillator.When the magnetic field is switched on, the defibrillator perceives interfering signals.The message appeared: "neck patch not connected".When checking all patches, they were all correctly glued and connected.The change was made from navx to voxel mode for a full impedance integration in voxel mode.In voxel mode, it was difficult to create a map, because the mapping catheter was frequently in low confidence and temporarily froze.The cs catheter was not correctly displayed, because of low confidence and excessive model bloating led to uncertainty.The study was successfully completed with no adverse patient consequences.
Additional Manufacturer Narrative
Based off of the information received from the field and review of the ensite x cardiac mapping system verifying that in some cases a model bloat/false space can occur, the reported event was confirmed.Recommendations to mitigate the model bloat/false space can be found in the ensite x cardiac mapping system ifu.

• Brand Name: ENSITE X EP SYSTEM DISPLAY WORKSTATION
• 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: 13891329
• Report Number: 2184149-2022-00086
• Device Sequence Number: 1764514
• Product Code: DQK
• UDI-Device Identifier: 05415067032171
• UDI-Public: 05415067032171
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2022

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-DWS-01
• Device Catalogue Number: ENSITE-DWS-01
• Device Lot Number: 8058423
• 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: 03/17/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• 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: Unknown