MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ENSITE¿ X AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-R-AMP-02
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a left-sided atrial flutter procedure, an orange light was noted on the amplifier as well as a software issue and the procedure was cancelled with no patient consequences.The procedure will be rescheduled.
Additional Manufacturer Narrative
One ensite x amplifier was received for evaluation.Visual inspection revealed the front ports, rear ports, and chassis show signs of wear consistent with use over time.For evaluation purposes ports 3 and 4 small form-factor pluggable (sfp) were temporarily exchanged.The amplifier was powered on and booted to a solid green ¿ready¿ light emitting diode (led) status indicating the amplifier passed the power-on-self-test (post) and successfully communicated with the test station tracker software.During analysis, the amplifier logs identified a warning message stating: ¿an under-voltage condition¿ for the 3 channels within the slot 4 cardiamp board.The message was followed by a slot 4 pmbus critical error which sent the amplifier into a blinking amber (error) state.The cardiamp was temporarily replaced isolating the symptom to the board originally in slot 4.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 the cardiamp board in slot 4.

• Brand Name: ENSITE¿ X AMPLIFIER
• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21761046
• Report Number: 2184149-2025-00068
• Device Sequence Number: 12923622
• Product Code: DQK
• UDI-Device Identifier: 05415067034748
• UDI-Public: (01)05415067034748(10)8072884
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K242016
• 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): 04/25/2025

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-R-AMP-02
• Device Catalogue Number: ENSITE-R-AMP-02
• Device Lot Number: 8072884
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• 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