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	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, there was a communication issue with the amplifier resulting in a clinically significant delay.While mapping, there were no issues.However, when ablation began, the catheter made instantaneous jumps into the atrium.The right veins were ablated first with some difficulty.The left veins could not be ablated because it was too difficult to visualize.After that, the hd grid x catheter extended a lot on the screen.A baseline reset was performed, and the entire map and ablation points were lost.During the second respiratory compensation, there was good stability with the catheter, and the issue had resolved.The troubleshooting and restarts took 30 minutes and were believed to be clinically significant by the physician.The procedure was completed with no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h2, h3, h6.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
Event or Problem Description
During an atrial fibrillation procedure, a communication issue was observed with the amplifier.While mapping, there were no issues.However, when ablation began, the catheter made instantaneous jumps into the atrium.The right veins were ablated first with some difficulty.The left veins could not be ablated because it was too difficult to visualize.After that, the hd grid x catheter extended a lot on the screen.A baseline reset was performed, and the entire map and ablation points were lost.During the second respiratory compensation, there was good stability with the catheter, and the issue had resolved.Troubleshooting and restarts took 30 minutes.The procedure was completed with no adverse patient consequences.The amplifier has been used in procedures since without issue.

• 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: 23070012
• Report Number: 2184149-2025-00153
• Device Sequence Number: 10065071
• Product Code: DQK
• UDI-Device Identifier: 05415067034748
• UDI-Public: (01)05415067034748(10)10687583
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/14/2025

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: 10687583
• Was Device Available for Evaluation?: No
• 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: 09/04/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2022
• 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