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	Electromagnetic Interference (1194)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an atypical atrial flutter ablation procedure, an error message was noted stating: "magnetic generator not connected" and the procedure was cancelled.Connections were checked and it was noted that the cable connection to the fieldframe was not connected properly.The pins in the cable were bent and touching one another.The cable was disconnected from the amplifier, and the pins were bent back into the normal position.The system was rebooted multiple times, but the issue persisted.The field frame and cable were then exchanged which did not resolve the issue.As a possible right sided tachycardia was seen on the inserted catheters, it was decided to map the right atrium in navx mode without sensor function.A possible substrate was seen, together with an activation map that could indicate right sided atypical flutter.Ablation was performed using tacticath se catheter and plugged in as a diagnostic catheter on the 20 pin pinboard, since it was not shown on ensite due to an issue with magnetics.Ablation was performed but the tachycardia persisted.Entrainment pacing was performed, indicating left sided tachycardia.It was decided not to insert catheters into the left atrium due to system issues and the procedure was cancelled.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3.One ensite x amplifier was received for evaluation.Visual inspection revealed the front ports and chassis were free of physical damage.Visual inspection of the rear ports revealed that the cat5e (ethernet sfp) was missing on return.For evaluation purposes, port 3 was temporarily installed with a known good cat5e small form-factor pluggable (sfp).The amplifier was powered on and booted to a solid green ¿ready¿ light emitting diode (led) status.This indicated the amplifier passed the power-on-self-test (post) and then successfully communicated with the test station tracker software.A field frame, patient reference sensors (prs-a single, prs-p triple), and a wet lab, were all connected into a magnetic study within tracker.As the identification of the eeprom was initiated, the ndi board could not detect the sensors.This symptom was then isolated to the sensor control unit (scu) board by means of temporary replacement with a known good scu.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 was attributed to electrical damage to the scu board.
Additional Manufacturer Narrative
Additional information: g3, h2, h3.The results of the investigation are inconclusive since the device was not returned for analysis.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 received, the cause of the reported electrical problem and subsequent cancellation remains unknown.

• 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: 16876386
• Report Number: 2184149-2023-00095
• Device Sequence Number: 20263188
• Product Code: DQK
• UDI-Device Identifier: 05415067032195
• UDI-Public: 05415067032195
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 06/16/2023

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: 7914873
• 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: 04/28/2023
• Supplement Date Received by Manufacturer: 05/17/2023; 06/15/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 05/18/2023; 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• 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