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 Codes	Erratic or Intermittent Display (1182); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the redo atrial fibrillation of posterior wall isolation and atypical atrial flutter procedure, the system lost the mapping catheter location.Disconnecting, removing, and reconnecting the catheter appeared to solve the issue initially, but later in the case when a redo of the map was attempted, the catheter location was lost and could not be restored.The issue was not resolved and the procedure was cancelled.There was no patient consequences.
Additional Manufacturer Narrative
The case study, collect logs, and photos were provided and reviewed.In regard to the 'no location messages', the system was operating as designed in those instances.After the metal baseline was reset, the voxel cloud was removed leading to the 'no location' messages even though the gumballs were green.In regards to the catheter location, review of the files showed the user set the visibility of the abl catheter to not visible, and from this point on, no catheters can be visualized in the study.In this, or any later segment, if the visibility of the abl catheter is set on, then catheters including the hd catheter can be visualized.It is recommended to turn on the visibility of the abl catheter in order to be able to visualize all catheters.

• 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: 13769966
• Report Number: 2184149-2022-00047
• Device Sequence Number: 4104567
• Product Code: DQK
• UDI-Device Identifier: 05415067041722
• UDI-Public: 05415067041722
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial,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: 8199365
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 120 KG