MAUDE Adverse Event Report: ST. JUDE MEDICAL 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	05/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, there was no connection to the field frame generator which resulted in a delay.The procedure was delayed approximately 45 minutes while another field frame generator and field frame connector cable were acquired from a secondary system within the facility.Further troubleshooting revealed that the field frame generator and field frame connector cable in question did not communicate with the ensite x system.The secondary field frame generator and field frame connector cable connected appropriately and were used to complete the case successfully without issue.
Additional Manufacturer Narrative
One ensite x ep system field frame was received.Evaluation testing was unsuccessful as the field frame was connected to the test station and no communication was established.Based on the information and investigation provided to abbott, the root cause was isolated to open electrical circus within the field frame.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformance associated with the reported event were identified.

• Brand Name: ENSITE X EP SYSTEM FIELD FRAME
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17072564
• Report Number: 2184149-2023-00118
• Device Sequence Number: 20501483
• Product Code: DQK
• UDI-Device Identifier: 05415067032195
• UDI-Public: 05415067032195
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 06/06/2023

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: 8736164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• 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: 05/25/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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