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

Model Number	ENSITE-FF-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a ventricular tachycardia (vt) ablation procedure, a communication issue occurred and the case was cancelled.During the procedure, the prs's were not displaying even though they were within the field frame.The system was rebooted, a new study was started, the patches were replaced, the prs-a and prs-p were swapped out.The field frame cable was unplugged, and the ends were swapped.There were no bent pins observed.The magnets issue was not resolved.The voxel study was closed and the procedure continued in navx mode with no magnets.The patient developed multiple vts so the physician didn¿t feel comfortable continuing the procedure in navx since the procedure had been scheduled specifically to be done in voxel mode.Therefore, the procedure was aborted with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3.One ensitex magnetic field frame 12 coil was received for evaluation.Visual inspection revealed the port, the chassis, and labels show signs of wear consistent with use over time.There was also numerous mars and divots to the entirety of the device.Additionally, a broken off cross-threaded support bolt was noted within the returned frame.The field frame was evaluated using a test station with tracker software, a test ensitex amplifier, patient reference sensors (prs-a single, prs-p triple) and a wet lab.Evaluation testing of the field frame was unsuccessful as the field frame identified many of the electrodes in strange locations due to the magnetic field not being created properly.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.Based on the investigation and information provided to abbott, the reported event was confirmed, and the root cause was attributed to a non-functioning field frame.

• Brand Name: ENSITE X EP SYSTEM FIELD FRAME
• 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: 16372271
• Report Number: 2184149-2023-00039
• Device Sequence Number: 15142869
• Product Code: DQK
• UDI-Device Identifier: 05415067032195
• UDI-Public: 05415067032195
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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-FF-01
• Device Catalogue Number: ENSITE-FF-01
• Device Lot Number: 7885571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown