MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE¿ X AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-R-AMP-02
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a pulmonary vein isolation and cavotricuspid isthmus procedure, the cavotricuspid isthmus portion of the procedure was aborted due to an ensite x amplifier communication issue.When the catheter was connected, a red signal was noted on the gui around the ampere connect port of the amplifier and the rf signal would not appear.No physical damage was noted.The amplifier was replaced.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h2, h3, h6.Additional information received confirmed that this is a duplicate event.This has been reported previously in manufacturing reference 2184149-2026-00003.Based on the information provided to abbott and the investigation performed, the reported event was able to be confirmed, and the root cause was attributed to electrical open to the ablation channels between the ampere connect port assembly and the front plane.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.
Event or Problem Description
Additional information received confirmed that this is a duplicate event.This has been reported previously in manufacturing reference 2184149-2026-00003.During a pulmonary vein isolation and cavotricuspid isthmus procedure, the cavotricuspid isthmus portion of the procedure was aborted due to an ensite x amplifier communication issue.When the catheter was connected, a red signal was noted on the gui around the ampere connect port of the amplifier and the rf signal would not appear.No physical damage was noted.The amplifier was replaced.There were no adverse consequences to the patient.

• Brand Name: ENSITE¿ X AMPLIFIER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24055065
• Report Number: 2184149-2026-00006
• Device Sequence Number: 15916753
• Product Code: DQK
• UDI-Device Identifier: 05415067034748
• UDI-Public: (01)05415067034748(10)10835089
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 02/20/2026

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: 10835089
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 105 KG