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	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a premature ventricular contraction ablation procedure with ensite x in voxel mode, a display issue occurred which caused a delay.The tacticath se was connected to the ampere, the ablation metrics (impedance, current, temperature, power) were displaying correctly on the ampere and cardiolab system, but not on the ensite x (despite the ampere symbol on the ensite x showing green for a successful connection most of the time).Then it intermittently flashed orange with an error saying the ampere was disconnected.A different fiber cable was tried between the ampere and the ensite x, as well as power cycling the ampere, but neither resolved the issue.At the end of the case, we rebooted both the ensite x dws and the amplifier, which was appeared to resolve the issue and the case was successfully completed without any patient consequences.
Additional Manufacturer Narrative
Corrected information: d1, d4.
Additional Manufacturer Narrative
The device was not returned for analysis.Review of the device history record was not possible as the serial number is unknown.Based on the information received, the cause of the reported communication issue remains unknown.

• 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: 14787099
• Report Number: 2184149-2022-00152
• Device Sequence Number: 17626282
• Product Code: DQK
• UDI-Device Identifier: 05415067041722
• UDI-Public: 05415067041722
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2022

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
• Operator of Device: Health Professional
• Device Model Number: ENSITE-DWS-1.1
• Device Lot Number: 8374261
• 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: 06/02/2022
• Supplement Date Received by Manufacturer: 09/14/2022; 09/19/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 09/14/2022; 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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
• Patient Sex: Unknown
• Patient Weight: 100 KG