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

Model Number ENSITE-AMP-02

Device Problems Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896); Power Problem (3010)

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

Event Date 12/10/2021

Event Type  malfunction  

Event Description

During an atrial fibrillation procedure, the connection between the ensite and the amplifier could not be established which caused a delay.The power was restarted, the position of the outlet was changed, the optical cable was exchanged, installation of isolation transformer was done, the power cable was replaced and all equipment was restarted, but the issue persisted.The same line was avoided at the outlet, and the connection was made by extending from the adjacent catheter room with no resolution.The connection was disconnected every 5 minutes and the amplifier status light changed from green to flashing orange.The amplifier was restarted and was green again, but the power of the amplifier was turned off, even though the load was not applied.Since 3d was required, it was changed to precision, and voxel mode had been applied, but was then changed to navx mode due to frequent connection troubles with the amplifier.However, the catheter could not be displayed in 3d.All the catheter presets were deleted and set manually, but the issue persisted.All catheter specifications were entered, and validation was performed several times; the catheter was hidden again and there was no improvement.There were no other alarms or messages.The procedure was completed without replacing the device and there were no adverse consequences to the patient.

Manufacturer Narrative

One ensite x amplifier was received for evaluation at tech center.The amplifier was powered on and the amplifier booted to a flashing amber led.This indicated the amplifier did not pass the power on self-test (post) and communication was unable to be established.A remote connection to the amplifier¿s terminal was established, and an evaluation of the post log identified the cardiamp board at slot 4 experienced a self-test failure.The power management bus check identified abnormal current output.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances associated with the reported event were identified.Based on the information provided to abbott and the investigation performed, the root cause was isolated to a non-functional cardiamp board.

Manufacturer Narrative

Correction: e1.

• 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: 13003706
• MDR Text Key: 284208894
• Report Number: 2184149-2021-00406
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067034755
• UDI-Public: 05415067034755
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 03/04/2022

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-AMP-02
• Device Catalogue Number: ENSITE-AMP-02
• Device Lot Number: 7870839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 02/11/2022; 03/04/2022
• Supplement Dates FDA Received: 02/23/2022; 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2021
• 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
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 78 KG