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	03/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an epicardial ventricular tachycardia (vt) procedure, the magnetic field frame was not recognized by the system in navx or voxel mode and a delay occurred.The prs a and prs p were exchanged which did not resolve the issue.The system was restarted 4 times without success.Disconnecting the cables from the amplifier and restarting did not resolve the issue.Disconnecting and re-connecting the frame cable did not resolve the issue.The procedure continued without magnetics and was completed with no consequences to the patient.
Additional Manufacturer Narrative
One ensite precision¿ magnetic field frame was received for analysis.Visual inspection of the returned field frame generator indicated no signs of physical damage; all labels are legible and correctly orientated.Functional testing revealed both patient reference sensors and all catheters tested were unable to be identified or tracked within the acquisition area.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 information provided to abbott and the investigation performed, the root cause of the reported event has been isolated to abnormal functionality of a non-serviceable system level component within the field frame assembly.

• 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: 13759919
• Report Number: 2184149-2022-00073
• Device Sequence Number: 2304594
• Product Code: DQK
• UDI-Device Identifier: 05415067032195
• UDI-Public: 05415067032195
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 05/06/2022

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-FF-01
• Device Catalogue Number: ENSITE-FF-01
• Device Lot Number: 8116667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/08/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• 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
• Patient Sex: Unknown