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

Model Number ENSITE-SYSTEM-01

Device Problems Electromagnetic Interference (1194); Application Program Problem (2880); Output Problem (3005)

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

Event Date 12/16/2021

Event Type  malfunction  

Event Description

During the procedure, several issues occurred resulting in the procedure being aborted.At the start of the procedure, there was baseline distortion present and an error message appeared stating "catheter in port 7 is invalid, because it has already been used with a different patient".The same error occurred for both the advisor hd grid and the tacticath se while they were already connected and inserted into the patient.The catheters were replaced, new ensite x surface electrodes were placed and validation was successful.At the same time, even if the metal baseline was set with a range of approximately 1.8, the caliper was always red, while the prs was green.An initial metal check was redone and a new baseline was taken.Additionally, the input port was also changed with no resolution.The system was rebooted, and an attempt was made to re-validate the study in navx mode, but the same issues occurred.In addition, during these checks, another error message was displayed "an error system occurred" and the system switched off.The procedure was aborted due to these issues with no patient consequences.

Manufacturer Narrative

Additional information: e1, g3.

Manufacturer Narrative

Review of the provided files showed that the catheter was connected in a different study with different patient identification information.In this scenario the system will restrict catheter use.If a new study is started with the same catheters connected, it is recommended to select the 'existing patient' option and choose the same patient.The system is operating as expected.Review of the provided files showed that the distortion meter exceeded ii, but did return below required range to become active.It is recommended to remove all metal far away from the patient and allow the metal level on the distortion meter to fall significantly below the threshold, and then reintroduce metal.The system is operating as expected.Review of the provided files for the displayed error: "an error system occurred" and suddenly, the system switched off" showed that the catheter was removed while software attempted to select its index from the catheter list.If a crash or freeze occurs, it is recommended to restart the system and resume the study.

• Brand Name: ENSITE¿ X EP SYSTEM
• 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: 13052062
• MDR Text Key: 282561310
• Report Number: 2184149-2021-00412
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2022

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-01
• Device Lot Number: 7868990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/07/2022
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 12/24/2021; 12/24/2021
• Supplement Dates FDA Received: 01/18/2022; 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• 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