MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE¿ X AMPLIFIER; Computer, diagnostic, programmable

Model Number	ENSITE-AMP-02
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One ensite x amplifier (sn: (b)(6) was received for evaluation.The field reported event was able to be duplicated by ic short testing.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 an electrical open to the channel 55 of the ampere connect port to the front plane assembly.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
During the supraventricular tachycardia procedure, signal issues resulted in a procedural delay.The ablation catheter electrode 3 was noisy and the electrode was not visualizing properly on the catheter.The ampere connect cables, ampere generator, tactisys and tactisys rf cable were all swapped, but the issue persisted.The electrode 3 was disconnected in the ensite catheter setup tab which allowed the catheter to display on the system properly, without electrode 3, but the ablation proximal signals could not be used and the procedure was able to be completed with 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22984998
• Report Number: 2184149-2025-00147
• Device Sequence Number: 21126476
• Product Code: DQK
• UDI-Device Identifier: 05415067034755
• UDI-Public: (01)05415067034755(10)8113418
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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-AMP-02
• Device Catalogue Number: ENSITE-AMP-02
• Device Lot Number: 8113418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2025
• 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: 08/13/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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