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

Model Number ENSITE-AMP-02

Device Problem Communication or Transmission Problem (2896)

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

Event Date 04/27/2023

Event Type  malfunction  

Event Description

During the atrial fibrillation procedure, communication issues with the display workstation resulted in the procedure being cancelled with no adverse consequences to the patient.The electrocardiograms and ensite x surface electrodes were connected but it was noted that the electrocardiogram was not displaying on ensite x.The electrocardiograms were showing on the non-abbott recording system (lab system pro).The amplifier and the display workstation were rebooted but the issue was not resolved.The system reference patches and the right leg electrocardiogram electrode were replaced but the issue still persisted.The procedure was rescheduled with no adverse consequences to the patient.

Event Description

During the atrial fibrillation procedure, communication issues with the amplifier resulted in the procedure being cancelled with no adverse consequences to the patient.The electrocardiogram and surface electrodes were connected but it was noted that the electrocardiogram was not displaying on the system.The electrocardiograms were showing on the non-abbott recording system (lab system pro).The amplifier and the display workstation were rebooted but the issue was not resolved.The system reference patches and the right leg electrocardiogram electrode were replaced but the issue still persisted.The procedure was rescheduled with no adverse consequences to the patient.

Manufacturer Narrative

Corrected information: b5.

Manufacturer Narrative

Additional information: d9, g3, g6, h2, h3, h6.One ensite x amplifier was received for evaluation at tech center.All ecg channels were successful.Based on the information provided to abbott and the investigation performed, the reported event was not able to be confirmed, and the root cause remains undetermined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: ENSITE X EP SYSTEM AMPLIFIER
• 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: 16853065
• MDR Text Key: 314371870
• Report Number: 2184149-2023-00094
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-AMP-02
• Device Catalogue Number: ENSITE-AMP-02
• Device Lot Number: 8444873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2022
• 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