MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X EP SYSTEM V1.1.1; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-SYSTEM-111
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a ventricular tachycardia (vt) procedure, a self-test issue occurred which caused a delay in procedure.Ensitex (2.0.1) was used in voxel mode in a patient with a non-abbott heart pump (impella).The contact force (cf) ablation catheter was used for mapping with contact force present.The cf catheter was exchanged for a diagnostic catheter and mapping was completed.The user went back to the cf catheter and there was no force; just dash lines.Troubleshooting included disconnecting and reconnecting the cf catheter with no resolution.The cf catheter was replaced and contact force was visible, but the light was red indicating the sensor was bad.Additionally, the electrodes were red and moving disjointedly.The cf catheter was replaced with a different ablation catheter (flexability) and the amplifier was restarted with no resolution.The study was then restarted which resolved the issue.Ablation was performed with the flexability and then switched back to using a cf catheter, which showed contact force and was visualized as expected.After ablating with the cf catheter, issues arose again with the sensor being red and the catheter moving.The case was able to be completed with no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: g3, h2, h3.A software review was not completed as there is no alleged complaint with the software.The cause of the reported communication issue and subsequent delay remain unknown.

• Brand Name: ENSITE¿ X EP SYSTEM V1.1.1
• 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: 16946350
• Report Number: 2184149-2023-00109
• Device Sequence Number: 12400937
• Product Code: DQK
• UDI-Device Identifier: 05415067041722
• UDI-Public: 05415067041722
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 08/08/2023

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-SYSTEM-111
• Device Catalogue Number: ENSITE-SYSTEM-111
• Device Lot Number: 8364138
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• 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