MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE X DISPLAY WORKSTATION V1.1; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number ENSITE-DWS-1.1

Device Problem Signal Artifact/Noise (1036)

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

Event Date 04/11/2023

Event Type  malfunction  

Event Description

Related manufacturing reference: 2184149-2023-00098.During the ventricular tachycardia ablation procedure, signal noise issues resulted in the procedure being cancelled.It was noted that there was a loss of both surface and intracardiac signals, the catheters were frozen on the screen but the live impedance numbers were still changing.It was possible to move through the tabs and menus without problems and load the different saved maps - suggesting the system was not frozen.The background of the waveform window turned blue and the electrogram lines turned purple.There were no error messages given from the system and the light on the front of the ensite x amplifier stayed solid green.Replacing the right leg lead, surface reference, and surfacelink did not resolve the issue.Rebooting the amplifier and dws restored the signals, however the procedure was already aborted and has not been rescheduled.

Manufacturer Narrative

Based on the logs submitted and information received, the reported event can be confirmed.The results of the investigation have determined that the amplifier, som (system on module) and slot 2 cardiamp, both had over current symptoms.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 DISPLAY WORKSTATION V1.1
• 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: 16886760
• MDR Text Key: 314754235
• Report Number: 2184149-2023-00097
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067037725
• UDI-Public: 05415067037725
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENSITE-DWS-1.1
• Device Catalogue Number: ENSITE-DWS-1.1
• Device Lot Number: 8532141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2022
• 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
• Treatment: ENSITE X EP SYSTEM AMPLIFIER