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

Model Number	ENSITE-DWS-1.1
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the premature ventricular contraction procedure, noise issues resulted in procedural delays.The display workstation and the amplifier were rebooted to resolve the issue and the procedure was completed with no adverse consequences to the patient.Mapping was completed with the mapping catheter.The ablation catheter was displayed on the monitor, the contact force was displayed normally, the electric potential was displayed on the recording system, but it was not displayed on the ensite side.Roving could be selected but waveform sensing was not possible, and points could not be acquired.The cable was reinserted with no resolution.The catheter was replaced another ablation catheter with no resolution.The second catheter was replaced, but the issue persisted.The display workstation and the amplifier were rebooted and the issue was resolved.The procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
Review of the ensite x system shows that a software issue exists that can cause the intracardiac electrogram waveforms to not display when using a preset.Abbott is aware of the issue and is working on a resolution.
Additional Manufacturer Narrative
Additional information: b5, d9, d10, g1, g3, g6, h2, h3, h6.Review of the ensite x software does not show the cause of the reported event.No log file data was provided, no further investigation is possible.Based on the information received, the cause of the reported noise issues remains unknown.
Event or Problem Description
Related manufacturing reference: 2184149-2023-00106.

• Brand Name: ENSITE X DISPLAY WORKSTATION V1.1
• 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: 16930160
• Report Number: 2184149-2023-00105
• Device Sequence Number: 15163751
• Product Code: DQK
• UDI-Device Identifier: 05415067037725
• UDI-Public: 05415067037725
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2023

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-DWS-1.1
• Device Catalogue Number: ENSITE-DWS-1.1
• Device Lot Number: 8224408
• 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: 04/21/2023
• Supplement Date Received by Manufacturer: 06/29/2023; 07/25/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 07/05/2023; 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENSITE X EP SYSTEM AMPLIFIER
• Patient Sex: Unknown